Framingham Cohort

1. Informed Consent & Tracking Procedures
   1. Informed Consent
   2. Consent by Substituted Judgment
   3. HIPPA - Release of Health Information for Research Purposes
   4. FHS Follow-up by Proxy
   5. Admitting Procedures
2. Phlebotomy
   1. Urine Specimen
   2. Blood Draw
   3. Glucose Tolerance Test
   4. Pregnancy testing
3. Clinical Measurements & Procedures
   1. Anthropometrics
      1. Weight
      2. Height
      3. Neck Circumference
      4. Waist Girth at Umbilicus
      5. Hip Circumference
      6. Thigh Circumference
      7. Sagittal Abdominal Diameter (SAD)
   2. Electrocardiogram (ECG)
   3. Ankle Arm Doppler (AAD) (participants 40 years and older)
   4. Observed Physical Performance
      1. Jamar Handgrip Strength
      2. Chair Stands (10)
      3. Fast Walk
   5. Pulmonary Function
      1. Spirometry (FVC)
      2. Diffusion Capacity
      3. Post-Albuterol Spirometry (select participants)
      4. Respiratory Questionnaire
   6. Tonometry and orthostatic blood pressure measurement
4. Tech-Administered Questionnaires
   1. Rosow-Breslau Functional Health Scale
   2. Fractures
   3. CES-D
   4. Exercise Questionnaire
   5. Neurocognitive Questionnaire
      1. CERAD
      2. Victoria Stroop
5. Self-Administered Questionnaires
   1. Socio-demographics
   2. SF-12 Health Survey
   3. Appetite Questionnaire
   4. Willett Dietary Questionnaire
6. Physician-Administered Medical History
   1. Medical History
   2. Resting Blood Pressure
   3. Physical Exam
7. Other
   1. Accelerometer

A short exam is completed when a participant requests an abbreviated exam (usually up to 2 hours of testing). A split exam is completed when a participant requests to do an examination in 2 visits.

The priority of exam procedures is listed below:

1. Informed Consent & Tracking Procedures
   1. Informed Consent
   2. HIPPA-Release of Health Information for Research Purposes
   3. Tracking Information Form
2. Clinical Measurements & Procedures
   1. Lab
      1. Blood
      2. Urine
      3. Glucose Tolerance Test
   2. Anthropometrics
      1. Weight
      2. Height
      3. Neck
      4. Waist at Umbilicus
      5. Hip
      6. Thigh
      7. Sagittal Abdominal Diameter (SAD)
   3. ECG
3. Physician-Administered Medical History and Physical Exam
   1. Medical History
   2. Resting Blood Pressure
   3. Physical Exam
4. Non-Invasive Vascular Testing
   1. Tonometry

If time permits for a short exam, the participant will undergo PFT and other measurement of vascular function (Ankle-Arm Doppler).

If the participant chooses to have a split exam a second date will be arranged to complete all of the remaining testing for the exam cycle.

1. Scale to measure body weight in lbs.: (2) Detecto Scale/ (1) Seca 700

   Worcester Scale Co., Inc.
   228 Brooks Street
   Worcester, MA
   508-853-2886

2. Weight to calibrate scale: 50 lbs.

   Worcester Scale Co., Inc. (See address above)

3. Accu Hite Stadiometer- (3) Seca 216

   Quick Medical
   425-831-5963
   888-345-4858

4. Heart Square by Heartware Inc.

   Purchased from: Nova Heart

5. Marquette Mac5000 (electrocardiogram cart)

   eGalEthCHare Technologies
   1701 Military Trail Suite 150
   Jupiter, FL 33468-9100

   Tech support:

   Sales Rep:

   Clinical Applications: 800-531-5613

6. Acquisition Module for Mac5000

   Cam-14 (see address above)

7. Mac PC (see information for Mac5000 above)

   backup portable ECG machine

8. Standard mercury column sphygmomanometer: Desk Top Baumanometer, (E98169)

   W.A. Baum Co., Inc
   620 OakStreet
   Copiague, NY 1172
   631-226-3940
   888-281-6061

9. Baumanometer blood pressure cuffs in four sizes: regular adult, large adult, pediatric and thigh.

   Inflation systems supplied by Moore Medical.

10. Litman stethoscope tubing and earpieces with bell: Classic II
11. Gulick retractable tape measure

    Novell Products
    P.O. Box 408
    Rockton, IL 61072
    815-624-4888
    800-323-5143

12. (2) Tailor’s fiberglass tape measure
13. Stopwatch -Water Resistant/Shock Resistant VCAT: 1045

    Fisher Scientific
    Atlanta, GA
    (800) 766-7000

    Calibration Only:

    Control Company
    4455 Rex Road
    Friendswood, TX, 77546
    281-482-1714
    Email: service/at/control3.com

14. Pulmonary Function Test (PFT), please see: Manual of Operations: Spirometry and Diffusion Capacity

    E-mail:

15. Spirometer: Collins CPL pf

    Collins Medical, Inc.
    220 Wood Road
    Braintree, MA 02184-2403
    800-225-5157

    Sales Rep/Customer Service:

16. 3 Liter Calibration Syringe S/N # 3729

    nSpire Health
    1830 Lefthand Circle,
    Longmont, CO 80501
    303-666-5555

17. Parts for Spirometer: (Nspire/Ferraris and Somerset Medical)
    1. KoKo Moe Disposable Filter and Mouthpiece w/ noseclips #810050
    2. Nafion Tubing #K381248
    3. PFT Adaptor #212147
    4. Disposable Hydrous Dessicator Column #K211501UK
    5. CO2 Absorbent Granules #K022556
    6. MicroTach #330672
    7. Balloons with O-Rings #K022355
18. Gases
    1. Oxygen Gas:
    2. Lung Diffusion Mix; .3%CO, .3%CH4,21% O2, BALN2

       Air Gas East
       27 North Western Drive
       Salem, NH 03079

19. Gait Timer System

    Multifunction Timer/Counter
    Model # 54035A

20. Laser Walk Test Contacts:
    1. BU Sargent College
       635 Commonwealth Ave.
       Boston, MA 02215
    2. BU Electronics Design Facility
       590 Commonwealth Ave.
       Boston, MA 02215
    3. BU School of Medicine
       Framingham Heart Study
       715 Albany St. B-608B
       Boston, MA 02118-2526
    4. Boston University
       Production Engineer CAS/ Electronic Shop
       590 Commonwealth Ave.
       Physics Room 2551
       Boston, MA 02215
21. JAMAR dynamometer

    Model #5030J1

    Sales Address:
    Sammons Preston
    14 N Peoria B-101
    Chicago, IL, 60607

    Calibration and Repair Address:
    Sammons Preston/ JLW Instruments, INC
    14 N Peoria B-101
    Chicago, IL 60607
    1-800-323-5547

22. Holtain Kahn Abdominal Caliper: ( Description Seritex Inc. 77748)

    Seritex Inc.
    1 Madison Street
    E. Rutherford, NJ, 07073
    (973) 472-4200
    Fax: (973) 472-0222

23. Actical Software- Version 2.1 and ActiReader with Instruction Manual

    Mini Mitter, a Respironics Company
    20300 Empire Avenue, Bldg. B-3
    Bend, Oregon 97701

    Customer Service: 800-685-2999

    Tech Support:

24. Accelerometer

    Mini Mitter, a Respironics Company
    20300 Empire Avenue, Bldg. B-3
    Bend, Oregon 97701
    www.minimitter.com

    Clinic Consultant:

1. Scales: Annually/Monthly/Daily (during clinic)
   • Room 100- Detecto
   • Room 101- Detecto
   • Room 102- Seca 700

   Protocol:

   1. Once a month scales are to be calibrated.
   2. Place a 50 lb weight onto the scale.
   3. Set the scale at zero.
   4. If scale is balanced then calibration is done.
   5. If scale is unbalanced then turn knob slightly on the side of the zero bar.
   6. Mark the date in the calibration log book located in the clinic office.
   7. Furthermore, scales must be certified on a yearly basis. This information can be found in the Clinic Equipment Book located in the clinic office.
2. Stadiometers: Monthly
   • Room 100- Seca Model # 216 1914009
   • Room 101- Seca Model # 216 1914009
   • Room 102- Seca Model # 216 1914009

   Protocol:

   1. Using the purple measuring tape located in the clinic office.
   2. Line up against the meter to determine correct marker points.
   3. Make sure to move up and down at different spots along the meter.
   4. If lines do not match up then a new stadiometer must be ordered.
   5. Mark date in calibration log book once a month.
3. Manometers: Monthly/ Daily (during clinic)
   • Room 100- V88290
   • Room 102- CE3201
   • Room 101- T30928
   • Room 107- T30927
   • Room 109- T30906
   • Spare- E95102 (located in clinic office rm.114)

   Protocol:

   1. Use the blood pressure calibrator located in the clinic office in the calibration equipment box.
   2. Make sure to place manometer on a flat surface and at eye level.
   3. Connect pieces making sure there is no leak and inflate.
   4. Slowly release pressure stopping along the way at random places.
   5. Make sure both meters read the exact same.
   6. Repeat for all five then mark in the Calibration Log Book located in the clinic office.
   7. If meter is off, the spare will be used while repairs are being made.
   8. Calibrate once a month.
4. Measuring Tape: Monthly
   • Room 100
   • Room 102
   • (2) Offsite

   Protocol:

   1. Use Purple Measuring tape located in the clinic office.
   2. Match up the two making sure they are exactly lined up.
   3. Move around the whole tape at random spots.
   4. If lines do not match then the tape has been stretched and a new one must be ordered.
   5. Once a month mark in Calibration Log Book.
5. Hand Grips : Annually/ Daily (during clinic)
   • Room 100- 10322924
   • Room 102- 30208097
   • Offsite- 10593388

   Protocol:

   1. The hand grips must be certified on a yearly basis.
   2. Use the Clinic Equipment Book for contact info.
   3. Handgrip should be at zero and documented on the daily log sheet.
   4. Offsite will be checked on a monthly basis and logged in the calibration book.
6. AED: Monthly
   • The AED is located in the clinic hall on stand outside of Room 109.

   Protocol:

   1. Once a month regular status (readiness) indicator checks are performed and recorded in Log Book.
   2. Also check and make sure that the spare battery and pads have not exceeded their expiration date.
7. Digital Timers: When certificate expires (around every two years)
   • Clinic #1- 72318431
   • Clinic #2- 72318449
   • Clinic #3- 22087033
   • Offsite #1- 22086935
   • Offsite #2- 61768767

   Protocol:

   1. Digital timers are calibrated about every two years.
   2. All information can be found in the Clinic Equipment Book.
8. Holtain Kahn Abdominal Caliper: Monthly
   • (2) In Clinic
   • (1) Offsite

   Protocol:

   1. Put Caliper on a FLAT Surface.
   2. Check to see if the Spirit Level (located at the top of the Caliper) is centered and the upper arm is even with the lower arm.
   3. If the Level is not centered and/or the arms are not even than the white screws on all four sides of the upper arm can be adjusted using a small screw driver located in the clinic office.
   4. There are also screws on the bottom that can be adjusted if arms are not leveling with the Spirit Level.
   5. Mark date in calibration log book once a month.
9. Digital Offsite Scales: Monthly
   • (2) Offsite Digital Scales

   Protocol:

   1. Use a 50 lb weight.
   2. Place scale on solid flat surface then place weight onto scale.
   3. Weight must be 50 lbs exact.
   4. Mark the date in Log Book once a month.
10. Blood Pressure Gauge: Monthly
    • (2) Offsite
    • (1) Used as a calibrator

    Protocol:

    1. All three gauges are Lifetime Certified, but they are still compared on a monthly basis for consistency.
    2. Attach pressure gauges and inflate pressure.
    3. Slowly release pressure making sure to stop at random spots for exact comparison.
11. Accelerometer: Every 6 Months
    • (100) devices

    Protocol:

    1. Replace batteries every 6 months.
    2. Replace rubber backing every 6 months.
    3. Time changes can be found in the program data.

CF Medical Inc,
12 Lakeview Ave.
Danvers, MA, 01923
978-750-1899

To ensure accuracy and legibility for persons performing data entry, adhere to the following guidelines:

1. Use a red or blue pen or any other pen which will stand out from the page (pencil or black ball-point pens are unacceptable).
2. Make sure all numerals are unmistakably clear.
3. If measurements are not taken enter 9’s (if the coding option is available) and document the reason. If the coding option of 9 is not available, leave blank and write any comments on why the questions were not asked. Comments are helpful at any point of the exam where data is not recorded in the standard manner.
4. If an error is made, cross the old value out with one line so original value is still visible, write the correct information in the margin, and initial and put the date the change was made. Do not superimpose numerals one on top of the other. It is always okay to write the reason for the change especially if it is not clear why.
5. Make sure both sides of the examination form are completed.
6. At the end of the exam a technician will review the entire exam and make sure all questions have been answered and that there are no blanks left on the form.
7. If a questionnaire was not administered check the following item at the top of the page and write in the reason why:

   |__| Check here if whole page is blank.   Reason why___________________________________

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

FRAMINGHAM HEART STUDY
73 Mt. Wayte Avenue
Framingham, MA 01702

RECORD OF IN-CLINIC MEDICAL ENCOUNTER

(to be filed in chart)

Participant’s ID#:____________   Participant’s Name:___________________________

Date of incident:______________

Description of incident:
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

Physician:__________________________________________

Follow up (if any)

Date of follow-up:__________________

___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

Physician/Staff:______________________________________

(to be filed in chart)

Participant’s ID#: ___-______   Participant’s Name:_____________________________

Date of Incident: ___/___/___

Person Contacted:_________________________________________________________
________________________________________________________________________

Regarding:_______________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

Contact Made By:_________________________________________________________

1. Was further medical evaluation recommended for this participant?

   This question is to be answered by the physician completing the chart.

   In addition to the physician writing in their physician ID number on the form, he/she will code this question using the following codes:

   • Coding
   • 0= No
   • 1= Yes
   • 9= Unknown

   If No, go to the next section.

   If Yes, the MD is to code the reason for further evaluation:

   1. Blood Pressure result ___/___

      Phone call > 200/110

      Expedite ≥180/100

      Elevated > 140/90

        Write in abnormality

   2. ECG abnormality _________________________________________
   3. Clinical Physician identified medical problem _________________________________________
   4. Other____________________________________________________

      _________________________________________________________

2. Was there an adverse event in clinic/offsite exam that does not require further medical evaluation?

   This question is to be completed by a staff member completing the exit interview.

   In addition to the staff member writing in their technician ID number on the form, he/she will code this question using the following codes:

   • Coding
   • 0= No
   • 1= Yes
   • 9= Unknown

   If Yes, write in any comments and photocopy this form and give to .

3. Was a FHS physician contacted during the examination due to adverse exam findings?

   This question is to be completed at offsite exams only by the staff member completing interview.

   In addition to the staff member writing in their technician ID number on the form, he/she will code this question using the following codes:

   • Coding
   • 0= No
   • 1= Yes
   • 9= Unknown

   If Yes, write in any comments regarding the telephone encounter.

4. Method used to inform participants of need for further medical evaluation

   This information is to be coded by the physician completed the chart.

   Circle ALL that apply

   • 1= Face-to-face in clinic
   • 2= Phone call
   • 3= Result letter
   • 4= Other
5. Method used to inform participant’s personal physician of need for further medical evaluation.

   This information is to be coded by the physician completed the chart.

   Circle ALL that apply

   • 1= Phone call
   • 2= Results letter mailed
   • 3= Results letter FAX’d
   • 4= Other

   Date referral made: ___- -___- -__ __ __ __ Use 4 digits for year

   ID number of person completing this referral:________

   Notes documenting conversation with participant or participant’s personal
   physician:_______________________________________________________________
   _______________________________________________________________________
   _______________________________________________________________________

Participant Label: _____________

Date of Visit: ___/___/___

Offsite Technician: ________________________________

The Framingham Study

* Please complete the upper portion of this form if you identify a new neurological event.

ID#:______________________ Name:______________________________

Date Opened: ___/___/___

Date of Event: ___/___/___ Date Type: ___ (0=Exact, 1= Approximate)

Source of Referral:__________

• 1 = Hospital Admission
• 2 = Biennial Exam
• 3 = Offspring Exam
• 4 = Family
• 5 = Medical Records
• 6 = Review
• 7 = Other (Please specify)

Initials:_________

Reason for Referral:_______________________________________________________

Reason for Hospitalization:_________________ (1=Neurology, 2=Other, 3=N/A)

Comments:______________________________________________________________
________________________________________________________________________
________________________________________________________________________

DISPOSITION (FOR TRACKING PERSONNEL TO COMPLETE)

1. Dictation:______________ (0=Awaiting, 1=In)
2. To be Scheduled in Stroke Clinic:___________ (0=No, 1= Yes, 2=Pending)
3. Date Seen in Stroke Clinic: ___/___/___
4. Reason Not Seen in Clinic:_________________(1=N/A, 2=Refused, 3=Deceased, 4=Out of State)
5. Part of PSIP Follow-Up Protocol:____________ (0=No, 1=Yes, 9=Unknown)
6. Previously Seen:____________ (0=No, 1=Stroke, 2=Dementia, 3=Other)
7. Medical Records needed: _________ (0=No, 1=Yes)
8. Date: ___/___/___
9. CT/MRI/MRA to be obtained:____________ (0=No, 1= Yes)
10. Date: ___/___/___
11. Review Status:_____________ (1=Awaiting Review, 2=Reviewed, 3=Need Info)
12. Date Reviewed:___/___/___
13. Status of Case:______________ (0=Opened, 1=Closed)
14. Date:___/___/___
15. Diagnosis:_________________________________________________________
    (1=Stroke, 2=TIA, 3=?TIA, 4=Parkinson’s, 5=No CVA, 6=Other Neuro, 7=Migraine, 10=?Stroke, 20=Recurrent TIA, 9=Unknown, 11=Multiple Sclerosis)

Dear___________________________:

We thank you for participating in the Framingham Heart Study. We have reserved a space for you in our clinic on ___________at _____________.

The Framingham Heart Study’s address is 73 Mt.Wayte Avenue, in the Perini Building. The Framingham Heart Study offices are located in the wing at the Franklin Street side of the Building. There is reserved parking for participants behind the Franklin Street wing. Please see the enclosed map. The building is handicap accessible.

You should bring slippers and if you choose, bring your own robe. In order to perform certain tests, we ask that you NOT eat after 8:00 P.M. the previous evening. You may have water, decaffeinated black coffee or tea (no creamer, milk or sugar) that evening and again in the morning before your appointment. A urine sample will be collected when you arrive.

Please do not wear jewelry because of the Bone Density Scan.

Please take any prescription medications, as you normally would.

Using the enclosed MEDICATION BAG, please bring all prescription and nonprescription medications you currently take or have taken in the past month in their original containers.

ON THE BACK OF THIS SHEET, please list information regarding hospitalizations and major illnesses you have experienced since your last exam or health history update.

PLEASE BRING THIS LETTER WITH YOU TO THE CLINIC. If you need help completing this form, Clinic staff can assist you at the time of your appointment.

If you have any questions, please call , Project Coordinator at locally and for long distance at

Sincerely yours,

Director
Framingham Heart Study

FHS REPORT GOES TO:

OVER →

Hospitalizations, Emergency Room Visits, or Day Surgery Since Your Last Clinic Visit

Doctor Office Visits:

Publication omitted

Fowkes FG, Murray GD, Butcher I, Heald CL, Lee RJ, Chambless LE, Folsom AR, Hirsch AT, Dramaix M, deBacker G, Wautrecht JC, Kornitzer M, Newman AB, Cushman M, Sutton-Tyrrell K, Fowkes FG, Lee AJ, Price JF, d'Agostino RB, Murabito JM, Norman PE, Jamrozik K, Curb JD, Masaki KH, Rodríguez BL, Dekker JM, Bouter LM, Heine RJ, Nijpels G, Stehouwer CD, Ferrucci L, McDermott MM, Stoffers HE, Hooi JD, Knottnerus JA, Ogren M, Hedblad B, Witteman JC, Breteler MM, Hunink MG, Hofman A, Criqui MH, Langer RD, Fronek A, Hiatt WR, Hamman R, Resnick HE, Guralnik J, McDermott MM. Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis. JAMA. 2008 Jul 9;300(2):197-208. [PubMed ID: 18612117], [ID : PMC2932628]

Health ABC - Operations Manual Vol. III - Chapter 3N, page 1

NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY III

Body Measurements (Anthropometry)

Westat, Inc.
1650 Research Boulevard
Rockville, MD 20850
(301) 251-1500

October 1988

3. EXAMINATION PROTOCOL

3.1. Eligibility Criteria

All SP’s aged two months and older are eligible for the body measurement component. Specific measurements are completed dependent on the age of the SP. Table 3-1 lists the SP age groups and the corresponding measurements.

3.2. Pre-Examination Procedures

3.2.1. Role of Anthropometric Examiner and Recorder

The collection of anthropometric data requires two health technicians for the roles of examiner and recorder. Health technicians for NHANES III are trained to perform both roles. However, the original examiner and recorder should complete an examination once it is started.

The examiner is responsible for positioning the SP, taking each measurement, and saying the measurement aloud to the recorder. The recorder repeats the number, enters it into the automated system (or hardcopy form), and says the name of the next measurement listed on the computer screen. The examiner should keep the measuring instrument set on the SP until the recorder repeats the number.

It is the recorders role to "assist" the examiner in obtaining correct measurements. This includes helping the examiner correctly position the SP and checking to make sure the SP is standing or sitting erect for specified measurements. The recorder also assists the examiner by checking the tension and horizontal position of the steel measuring tape for girth measurements.

The recorder has the responsibility of ensuring that correct data are entered into the automated system (or recorded on the hardcopy form). The recorder, having had the same training as the examiner, should recognize a gross error in measurement or in reading the different instruments. When an error is recognized, the recorder should call it to the examiner’s attention and the measurement should be repeated.

Table 3-1. Body measurements by age

3.2.2. Measuring and Recording Guidelines

Body measurements are always taken on the right side of the body. However, some measurements may be taken on the left side of the body because of casts, amputation, or other reasons. When this occurs, the reason is noted in the comments section on the body measurement results screen or hardcopy form by the recorder.

All measurements, except skinfolds, should be taken to the nearest tenth of a centimeter or 1.0 millimeter. Skinfold measurements are taken to the nearest 0.1 millimeter. Measures that exceed specific limits on the computer will be repeated by each technician.

All skinfold measurements will be done in duplicate (i.e., by two different technicians or twice by the same technician) since these measures have the most variability.

If a skinfold is too tight to be measured the code for "tight skin" should be recorded in the space for that skinfold on the computer or hardcopy form. If a skinfold is above the measurable limits of the calipers, the code for "50+" should be entered in the recording space for that skinfold.

3.3. Examination Procedures

3.3.1. Protocol Procedures

3.3.1.1. Weight

The electronic digital scale should be in the kilogram mode. It is not, press the LB/KG key on the keyboard face. The digital LED readout should show 000.00 before weighing a sampled person. If it does not, press the zero key on the keyboard scale to zero the scale.

Have the sampled person stand on the center of the weight scale platform. Record the weight in kilograms in the automated system or on the body measurement exam form in the appropriate space.

Since the scale printer will only print to 250 pounds, the following procedure must be followed if an SP weighs more than 250 pounds:

1. If the SP weighs more than 250 pounds, but no more than 350 pounds:
   1. Move the bottom weight on the notched bar on the front of the scale to 100 pounds (far right).
   2. Weigh the examinee and press the KG key on the keyboard just as though he weighed less than 250 pounds.
   3. Add 45.36 kilograms (100 pounds) to the weight.
   4. Record the total weight (stamped weight plus 45.36 kilograms) in the automated system or in the proper space on the body measurement exam form.
2. If the examinee weighs more than 350 pounds, but no more than 400 pounds:
   1. Move the bottom weight on the notched bar to 100 pounds.
   2. Move the top weight on the numbered bar to 50 pounds (far right).
   3. Weigh the examinee and press the KG key just as though he weighed less than 250 pounds.
   4. Add 68.04 kilograms (150 pounds) to the weight.
   5. Record the total weight (stamped weight plus 68.04 kilograms) in the automated system or in the proper space on the body measurement exam form.
3. If the examinee weighs more than 400 pounds ask him to estimate his weight and document this estimation in the comments section of the automated system.

3.3.1.2. Standing Height

Have the SP stand erect on the floor board of the stadiometer with his or her back to the vertical backboard of the stadiometer. The weight of the participant is evenly distributed on both feet. The heels of the feet are placed together with both heels touching the base of the vertical board. Place the feet pointed slightly outward at a 60 degree angle (see Exhibit 3-1). If the SP has knock knees, the feet are separated so that the inside of the knees are in contact but not overlapping. The buttocks, scapulae, and head are positioned in contact with the vertical backboard. It may not be possible for some children and most adults to place their heels, buttocks, scapulae and the posterior aspect of the head against the backboard while maintaining normal stature. Such SP’s are positioned so that only the heels and buttocks are in contact with the vertical board, and the body is positioned vertically above the waist. The arms hang freely by the sides of the trunk with palms facing the thighs.

Exhibit 3-1. SP position for standing height

The SP is asked to inhale deeply and to stand fully erect without altering the position of the heels. The SP’s head is maintained in the Frankfort Horizontal Plane position while the examiner lowers the horizontal bar snugly to the crown of the head with sufficient pressure to compress the hair. Hair ornaments, buns, braids, etc. must be removed to obtain an accurate measurement. The bar is locked in place and one of the sample number labels placed next to the tape on the upright bar so that the label can be read on the standing height measurement photograph. The examiner needs to make sure that the hair of the SP does not obscure the scale when the photograph is taken. After the measurement is read from the photograph by the examiner and recorded by the recorder to the nearest 0.1 cm.

3.3.1.3. Sitting Height

For measuring sitting height, the examiner moves the specially-made measurement box onto the floor board of the stadiometer. The right leg of the SP’s exam pants need to be cut up the leg so that the skin can be marked for thigh and calf measurements. Reassure the sampled person that the pant leg will be re-taped after the body measurements are completed. The SP then sits on the box with his or her back and buttocks to the backboard of the stadiometer. The SP sits as erect as possible with the head in the Frankfort Horizontal Plane. The knees are directed straight ahead with the arms and hands resting at the sides (see Exhibit 3-2). Ask the SP to sit tall, take a deep breath, and then bring the horizontal bar down snugly to the head. The SP’s head is maintained in the Frankfort Horizontal Plane position while the examiner lowers the horizontal bar snugly to the crown of the head with sufficient pressure to compress the hair. The bar is locked in place and one of the sample number labels placed next to the tape on the upright bar so that the label can be read on the measurement photograph. The examiner needs to make sure that the hair of the SP does not obscure the scale when the photograph is taken. After the sitting height measurement is photographed and the film processed, the sample number label from the upright bar is placed on the photo. The measurement is read from the photograph by the examiner and recorded by the recorder to the nearest 0.1 cm.

Exhibit 3-2. SP position for sitting height

3.3.1.4. Upper Leg Length

The SP sits straight on the measuring box with the right knee bent at a 90 degree angle. The small sliding caliper (used to measure elbow breadth) is positioned as if one were to measure the breadth of the patella. The blades of the caliper are positioned against the distal end of the femur on either side of the patella. The horizontal bar of the caliper should be touching, or close to the anterior surface of the thigh, proximal to the patella. Using the superior edge of the horizontal bar of the caliper as a guide, mark a line on the anterior surface of the thigh. The steel measuring tape is placed at the inguinal crease which is easily located if the hips are in a sitting position. No pressure is to be applied at the inguinal crease; however, folds of fat tissue may have to be lifted on some obese SP’s to measure at the crease. The exam gown should be lifted and the pants slightly pulled to smooth out gathers. The tape is extended along the midline of the thigh to the line just proximal to the patella (see Exhibit 3-3). The length of the upper leg is called to the recorder and the examiner also makes a (+) at the mid point of the thigh with the cosmetic marker. This point will be used at a later time for the thigh circumference and the thigh skinfold.

3.3.1.5. Knee Height

Knee height is only measured on adults 60 years of age and older. To obtain the measurement, the SP sits on the examination table with both legs dangling. The SP may require the assistance of the examiner to help him onto the table. The examiner places the fixed blade of the large sliding caliper under the heel of the right leg just below the lateral malleolus of the fibula. From a squatting position, the examiner raises the leg so that the knee and ankle are both at a 90 degree angle (see Exhibit 3-4). This is best accomplished by resting the SP’s foot in the palm of the examiner’s hand. The moveable blade of the caliper is placed on the anterior surface of the right thigh, above the condyles of the femur, about two inches above the patella. The shaft of the caliper is held parallel to the shaft of the tibia so that the shaft of the caliper passes over the lateral malleolus of the fibula and just posterior to the head of the fibula. Pressure is applied to compress the tissue. The recorder checks the positioning of the leg and the caliper. Knee height is recorded to the nearest 0.1 cm.

Exhibit 3-3. SP position for upper leg length location and upper leg midpoint

Exhibit 3-4. SP position for knee height

3.3.1.6. Biacromial Breadth

The SP sits on the body measurement table which is approximately chair height. The SP is asked to sit erect with the arms hanging freely at the sides. The examiner stands behind the SP with the mediform sliding calipers. The examiner checks the posture of the SP making sure that the shoulders are neither too far back nor forward, and that there is a noticeable curvature in the lower back. The objective is to have the SP relaxed with the shoulders downward and slightly forward so that the reading is maximal. The sleeves of the exam gown are pulled up towards the neck rather than pulling the gown down over the shoulders. The examiner then locates the acromial process. The caliper rests gently between the thumb and forefinger of the examiner. This allows the examiner to palpate the bony ridges with his other fingers. The examiner locates the lateral border of the acromial process on each shoulder. The arms of the sliding caliper are placed directly on the skin next to the lateral border of each acromial process and pressure is applied to compress the soft tissue over the acromial processes without hurting the SP. The maximum breadth across the lateral borders of the acromial processes is measured to the nearest 0.1 cm.

3.3.1.7. Biiliac Breadth

The SP stands erect with feet together. The SP needs to hold the examination gown up so that the waist and top of hips are exposed. The examiner stands behind the SP holding the large sliding calipers. At the same time, the examiner locates the right side of the iliac crest at its highest point. At this point, the arms of the sliding caliper are placed on the lateral borders of each iliac crest. The soft tissue is compressed to obtain the bone measurement without hurting the SP. The maximum breadth at the highest point of the iliac crests is measured to the nearest 0.1 cm.

3.3.1.8. Upper Arm Length

Have the SP stand erect with feet together and the right arm flexed 90 degrees at the elbow with the palm facing up. The examiner is positioned behind the SP. The most upper edge of the posterior border of the acromion process of the scapula is located and marked (see Exhibit 3-5). Hold the zero end of the measuring tape at this mark and extend the tape down the posterior surface of the arm to the tip of the olecranon process (the bony part of the mid-elbow). Read the measurement aloud to the recorder. Keep the tape in position and locate half the distance from the acromion to the olecranon processes, i.e., the midpoint of the upper arm. With the cosmetic pencil, mark (+) at the midpoint on the posterior of the arm. This location will be the site for the mid arm circumference and triceps skinfold.

Exhibit 3-5. SP position for arm length position and location of upper arm midpoint

3.3.1.9. Arm Circumference

The SP is standing with the elbow relaxed so that the right arm hangs freely to the side. The examiner stands facing the SP’s right side. The measuring tape is placed around the upper arm at the marked point perpendicular to the long axis of the upper arm (+ from upper arm length). The tape is again held so that the zero end is held below the measurement value. The tape rests on the skin surface, but is not pulled tight enough to compress the skin. The arm circumference is recorded to the nearest 0.1 cm.

3.3.1.10. Abdominal (Waist) Circumference

The SP is in a standing position. The SP is asked to hold up his gown. The examiner stands behind the SP and palpates the hip area for the right iliac crest (see Exhibit 3-6). The examiner marks a horizontal line at the high point of the iliac crest and then crosses the line to indicate the midaxillary line of the body. The pants and underclothing of the SP must be lowered slightly for the examiner to palpate directly on the hip area for the iliac crest. The examiner then stands on the SP’s right side and places the measuring tape around the trunk in a horizontal plane at this level marked on the right side of the trunk. The recorder walks around the SP to make sure that the tape is parallel to the floor and that the tape is snug, but does not compress the skin. The measurement is made at minimal respiration to the nearest 0.1 cm.

Exhibit 3-6. Measuring tape position for abdominal (waist) circumference

3.3.1.11. Buttocks (Hip) Circumference

The SP stands erect with feet together and weight evenly distributed on both feet. The SP is holding up the examination gown. The recorder stands in back of the SP and gathers the side seams of the exam pants together above the hips and places the thumb in the fabric to make a fold. The recorder holds the folded sides of the pants snugly while the examiner squats on the right side of the SP and places the measuring tape around the buttocks. The tape is placed at the maximum extension of the buttocks (see Exhibit 3-7). The recorder then adjusts the sides of the tape and checks the front and sides so that the plane of the tape is horizontal. The zero end of the tape is held under the measurement value. The tape is held snug but not tight. The examiner takes the measurement from the right side and calls it to the recorder.

3.3.1.12. Thigh Circumference

The SP is standing with the right leg just in front of the left leg and the weight shifted back to the left leg. This instruction should be demonstrated by the examiner. The edge of the examining table may be used for the SP to hold onto to maintain his balance. The examiner stands on the SP’s right side and the measuring tape is placed around the midthigh at the point that is already marked by a (+). The tape is positioned perpendicular to the long axis of the thigh with the zero end of the tape held below the measurement value. The tape rests firmly on the skin without compressing the skin. The recorder checks to make sure the tape is positioned correctly. The thigh circumference is measured to the nearest 0.1 cm.

3.3.1.13. Skinfolds

All skinfolds are measured with the Holtain skinfold calipers. The measurements are taken on the right side of the body. The fold of skin and underlying subcutaneous adipose tissue should be gently grasped between the examiner’s left thumb and forefingers. The amount grasped depends upon the thickness of the subcutaneous adipose tissue. The examiner grasps enough skin and adipose tissue to form a distinct fold that separates from the underlying muscle. The sides of the fold should be roughly parallel. The skinfold is grasped 2.0 cm above the place the measurement is to be taken and is held gently with the thumb and forefinger. The jaws of the calipers are placed at the marked level, perpendicular to the length of the fold, and the skinfold thickness is measured to the nearest 0.1 mm while the fingers continue to hold the skinfold. The actual measurement is read from the caliper about 3 seconds after the caliper tension is released. A young child is unfamiliar with this procedure; therefore explain the procedure and demonstrate the use of the caliper on the child’s palm. All skinfolds are recorded to the nearest 0.1 mm.

Exhibit 3-7. Measuring tape position for buttocks circumference

• Thigh Skinfold

  The thigh skinfold is measured in the midline of the anterior aspect of the right thigh. This level has already been marked from the thigh circumference measurement. The SP stands with his weight shifted back on the left leg with the right leg forward, knee slightly flexed, foot flat on the floor. Some SP’s will need to hold onto the edge of the table to maintain their balance in this position. This is the same position used for measuring the thigh circumferences. A fold of skin and subcutaneous tissue is grasped in the midline about 2.0 cm above the marked point. The jaws of the skinfold calipers are placed perpendicular to the length of the fold and the shaft of the thigh over the marked point. Skinfolds are recorded to the nearest 0.1 mm.

• Triceps Skinfold

  The SP stands erect with feet together, shoulders relaxed and the arms hanging freely at the sides. The examiner stands behind the SP’s right side. The point on the posterior surface of the right upper arm is located in the same area as the marked midpoint for the upper arm circumference. A fold of skin and subcutaneous adipose tissue is grasped gently with thumb and fingers approximately 2.0 cm above the marked level with the skinfold parallel to the long axis of the arm (see Exhibit 3-8). The jaws of the calipers are placed at the marked level, perpendicular to the length of the fold, and the skinfold thickness is measured to the nearest 0.1 mm while the fingers continue to hold the skinfold.

  Exhibit 3-8. Location of triceps skinfold

  

• Subscapular Skinfold

  The SP stands erect with shoulders and arms relaxed at the side. The examiner opens the back of the examination gown and palpates for the inferior angle (or triangle portion) of the right scapula. The examiner makes a (+) on the inferior angle of the scapula with the cosmetic pencil marker. The examiner grasps a fold of skin and subcutaneous adipose tissue directly below (1.0 cm) and medial to the inferior angle. The skinfold forms a line about 45 degrees below the horizontal extending diagonally toward the right elbow (see Exhibit 3-9). The jaws of the caliper are placed perpendicular to the length of the fold about 2.0 cm lateral to the fingers with the top jaw of the caliper on the mark over the inferior angle of the scapula. The skinfold thickness is measured to the nearest 0.1 mm while the fingers continue to hold the skinfold.

• Suprailiac Skinfold

  The SP stands and holds the right side of the examining gown up so that the right hip area is exposed. It may be necessary to lower the exam pants slightly to expose the area. The iliac crest had already been marked from previous measurements. The examiner places his/her thumb (left) on the intersecting marks and picks up the skinfold with the thumb and fingers. The skinfold should slope downward and forward at a 45 degree angle extending toward the pubic symphysis (see Exhibit 3-10). The caliper is placed perpendicular to the skinfold about 2.0 cm medial to the fingers and the skinfold is measured to the nearest 0.1 mm.

3.3.1.14. Elbow Breadth

The SP stands erect with feet together facing the examiner. The right arm is extended forward until it is perpendicular to the body. The examiner then flexes the right arm of the SP so that the elbow forms a 90 degree angle with the fingers pointing up and the posterior part of the wrist toward the examiner. With the small sliding caliper held at a 45 degree angle to the plane of the long axis of the upper arm, the greatest breadth across the epicondyles of the elbow are measured to the nearest 0.1 cm. This measurement is taken with the calipers at a slight angle because the medial condyle is more distal than the lateral condyle (see Exhibit 3-11).

Exhibit 3-9. Location of subscapular skinfold

Exhibit 3-10. Location of suprailiac skinfold

Exhibit 3-11. SP position for elbow breadth

3.3.1.15. Wrist Breadth

The SP stands and extends the right arm keeping the arm straight and near the side of the chest. The examiner stands to the right side of the SP and guides the blades of the small sliding caliper with the thumb and first finger of each hand. The examiner palpates the most prominent aspect of the ulnar styloid process with the middle or index finger of the right hand and slides the right blade of the caliper on to this landmark (see Exhibit 3-12). The most prominent aspect of the radial styloid process is located with the middle or index finger of the left hand. Firm pressure is applied and the breadth is recorded to the nearest 0.1 cm.

Exhibit 3-12. Bones of the wrist

3.3.1.16. Sequence of Measurement Components, SP Position, and Examiner Equipment for Adults 20+

Measurement		SP Position	Equipment
1.	Weight	Standing	Scale
2.	Standing height	Standing	Stadiometer Polaroid Camera
3.	Sitting height	Sitting right pant leg open	Measurement box Stadiometer
4.	Upper leg length (mid mark is placed on SP)	Sitting on box right pant leg open	Measurement box Small sliding caliper Insertion tape Cosmetic pencil
5.	Knee height *60+ only	Sitting on exam table	Mediform sliding caliper
6.	Biacromial breadth	Sitting on exam table	Mediform sliding caliper
7.	Biiliac breadth	Standing hold gown up	Mediform sliding caliper
8.	Upper arm length (mid mark is placed on SP)	Standing	Insertion tape Steel tape Cosmetic pencil
9.	Arm circumference	Standing	Steel tape
10.	Abdominal circumference (mark iliac crest)	Standing hold gown up	Steel tape Cosmetic pencil
11.	Buttocks circumference	Standing hold gown up	Steel tape
12.	Thigh circumference	Standing hold gown up right pant leg open	Steel tape
13.	Thigh skinfold	Standing hold gown up right pant leg open	Skinfold caliper
14.	Triceps skinfold	Standing	Skinfold caliper
15.	Subscapular skinfold	Standing	Skinfold caliper
16.	Suprailiac skinfold	Standing hold up gown	Skinfold caliper
17.	Elbow breadth	Standing	Small sliding caliper
18.	Wrist breadth	Standing gown down	Small sliding caliper

3.3.1.17. Measuring Children under Eight Years of Age

The same procedures are followed for measuring stature and weight of children aged two through seven years as used for older SP’s. For measuring breadths, circumferences, or skinfolds, the child may stand on a footstool placed in the center of the measuring room. If the child is too young to sit or stand by himself, the measurements are taken with the child sitting in the parent’s lap. The examiner’s eyes must be level with the calipers to prevent parallax. Otherwise, use the same procedures as that for older SP’s.

• Recumbent Length

  Place children 3 years of age and younger supine on the infant measuring board. The recorder holds the child’s head in the Frankfort plane and applies gentle traction to bring the head into contact with the fixed headboard. The examiner holds the child’s legs by placing one hand gently but firmly over the knees with the child’s toes pointing directly upward. By applying gentle pressure to the legs to prevent the knees from flexing, the examiner brings the movable footboard to rest firmly against the child’s heels. The measurement is recorded to the nearest 0.1 cm from the digital counter on the measuring board. It may be necessary to have a third person help with restless infants to take the measurement as quickly as possible while maintaining accuracy.

• Head Circumference

  This measurement is done on children 2 months to 7 years of age. The child either sits in the parent’s lap, on the footstool, or stands depending upon age and activity level. The tape is placed across the frontal bones just above the eyebrows, around the head above the ears on each side, and over the occipital prominence at the back of the head. The examiner holds the tape snugly around the head. Hair ornaments and braids should be removed. The tape is moved up and down over the back of the head to locate the maximal circumference of the head. The tape should be perpendicular to the long axis of the face and should be pulled firmly to compress the hair and underlying soft tissues. Record the measurement to the nearest 0.1 cm.

3.3.1.18. Measuring Handicapped SP’s

For those SP’s that are handicapped (in wheelchairs) only limited anthropometric data can be collected.

• Weight can be recorded using the tared wheelchair in the MEC.
• Upper arm length is measured as if the SP were standing. It is necessary to position the SP over to the right side of the wheelchair so that the right arm is not restricted by the arm of the chair.
• Arm circumference is also measured as if the SP were standing. The SP should be in the same position in the wheelchair as for measuring upper arm length. Again, it is important that the right arm is extended so that it is not restricted by the arm of the wheelchair.
• Triceps skinfold is measured on the back of the right arm as if the SP were standing. The position of the SP and the right arm are the same as for measuring arm circumference.
• Knee height can be recorded from the right lower leg as if the SP were ambulatory. It is necessary to remove or rearrange parts of the wheelchair so that there is no interference with the measurements. Again it is important that both the knee and ankle are each at 90° angles.
• Head circumference can be recorded in the same manner as an ambulatory child.
• Wrist and elbow breadths can also be easily recorded from an SP in a wheelchair. The same procedures are followed but the SP is seated rather than standing.

3.3.2. Examination Form

3.3.2.1. Automated System

The automated system for the Body Measurement examination will consist of several screens: an introductory screen, data collection screens and an exit screen. Data collection screens are designed to display descriptions of the measurements to be done for each age group. If an SP is less than two years of age, only the measurements applicable to that age group will be displayed on the screen. Likewise, if an SP is 2+ years of age, only the measurements applicable to each age group will be displayed on the screen. Different measurements are collected for SP’s 2 months or greater, 2 years or greater, 60 years or greater, 2 months to 3 years and 2 months to seven years of age.

All measurement entries will be automatically edited for entry of a decimal point. If a decimal point is missing or incorrectly placed, a message will be displayed and the cursor will not advance until the decimal problem is corrected. Measurement entries will also be edited for length. If the number of positions entered for a measurement exceeds the number of positions allowed for that measurement, a message will be displayed and the cursor will not advance until the problem is resolved. Values which fall outside of specified boundaries for body measurements will be flagged for immediate verification. The technician will either verify the original value or enter the second "correct" value.

Every other day, one SP will be selected by the computer to have body measurements replicated by another technician. This selection will be made after the first set of measurements are completed. All body measurements will be repeated for these SP’s.

• Introductory Screen

  Five procedures or functions are automated for the body measurement examination room. These functions will be performed under the control of a menu system. When a function is selected from the main menu, screens for the selected application will be displayed.

  Selecting "data collection" from the main menu will bring up the introductory screen and allow entry into the data collection forms. The purpose of the introductory screen is to establish the identity of both the technician and the SP and to establish examinations required of the SP for each MEC room. After the technician enters the SP ID number, identification data for the SP will be sent to the body measurement screen by the scheduling system.

  Only procedures required for the SP will be displayed on the introductory screen. Although allergy and body measures will be done in the same room, only SP’s ages 6-19 and SP’s ages 20-59 with an even NCHS number will receive an allergy examination. All SP’s will receive a body measurement examination.

  The Introductory Screen appears as follows:

  

• Data Collection Screens

  After selecting the appropriate procedure for an SP, the data collection screens will be displayed. If an SP is ages 12-16, the first data collection screen will be as follows:

  

  The technician will ask the SP these two questions before obtaining any measurements. Again, this screen is only displayed and completed for SP’s 12-16 years old.

  These data collection screens will be displayed for SP’s less than two years of age.

  

  Technicians are required to enter a decimal point for each measurement entry.

  The replicate skinfold screen follows the measurement screens. Only two skinfolds are repeated for SP’s less than two years of age.

  

  The second technician (Tech B) will measure the skinfolds and record the values. Discrepancies between the skinfold measures of two technicians are allowed within certain tolerance levels. If the discrepancy exceeds these levels, the measurement will be flagged with a "*" and a message will be displayed at the bottom of the screen to measure and record the skinfold measurement again.

  

  These are screens for two year olds. Similar screens will be displayed for other ages. The cursor will move from measurement field to next measurement field. If the technician wants to enter a comment (i.e., tight skin) the "Insert Here" key will move the cursor to the comment field and then back to the measurement screen. A list of comments and codes will be placed near the terminal for reference and are also listed on the hardcopy exam form. If a code is not available, specific comments may be entered at the end of the exit screen.

  

  After the measurement screens are completed, the height photo screen will be displayed for all SP’s ages 2 years and older. This screen verifies that height photos were obtained and this information will also create a shipping record for the photos.

  

• Results Screens

  The results of examination screen displays at the conclusion of every MEC examination.

  

  If "Test Done" is selected, the automated system will return to the introductory screen. If "Test Incomplete" or "Test Not Done" is selected, the "Reasons Test Incomplete or Not Done" screen will be displayed.

  

  The technician will select the most appropriate reason for an incomplete or unattempted exam. If the reasons displayed do not apply, select "Other" and record reason in "Comments." The "Comments" field can always be utilized for any additional comments the technician thinks is applicable to the body measurement examination.

3.3.2.2. Hardcopy Data Form

When the automated system is not functioning, the body measurement data are recorded on hardcopy data forms (see Exhibit 3-13). The recorder enters the SP’s identification number, or label at the top of the form. The examiner ID# is also recorded. The recorder must then verbally prompt the examiner as to which measurements are applicable to the SP according to age. All of the possible exam components are listed on the hardcopy data form. It is the responsibility of the recorder to carefully monitor the form to make sure only the correct measurements are performed.

Exhibit 3-13. Body measurements (all ages)

The "Results of Examination" code should be selected after the measurements are obtained. If "Test Incomplete" or "Test Not Done" is selected, a reason from the "Reasons Test Incomplete or Not Done" list must be selected.

Page two of the hardcopy data form also includes the list of codes that are used when a measurement is unable to be taken. These codes are the same comment codes that are entered into the automated system for unobtained measurements.

After the exam is completed, hardcopy data forms are placed in the SP chart with other completed data forms. If hardcopy data forms are used because the automated system is not functioning, the data from the hardcopy forms must be carefully enterd into the computer when it returns to working order as per instructions from the MEC manager.

3.4. Postexamination Procedures

After completion of the body measurement examination, the technician should remove all cosmetic pencil marks off the SP with some alcohol or baby oil on a piece of gauze. Technicians should direct or accompany SP’s to their next examination destination as per MEC procedures.

This section describes additional procedures for the Body Measurement component that are the responsibility of the health technicians. These procedures include completing records, logs, and transmittal forms for the recording and shipment of examination data. The accurate completion of these procedures help facilitate an organized data collection process.

4. LOGS AND RECORDS

4.1. Daily Appointment Schedule

The Daily Appointment Schedule will provide information for several uses. A copy of the schedule will be given by the coordinator to the health technicians for the next day. the form from the automated system will provide a copy with the name, age, and sample numbers for each SP scheduled for that day. This list can be used to verify the Daily Log Sheet and other forms. It also lists the number of SP’s that are expected for the session.

4.2. Daily Log

The automated system serves as a daily log to record information about each SP. However, if the system is malfunctioning, hardcopy logs will be maintained.

Daily log sheets are to be completed in addition to the automated system until instructed otherwise by the MEC manager (see Exhibit 4-1). The daily log sheet is located on a clipboard in the body measurement room. One page is used every session that examinations are being conducted during a stand. The technician completes the date, the session time, the stand number, and location.

Exhibit 4-1. Body measurement daily log sheet

Exhibit 4-2. Equipment calibration log

For each SP examined, the technician records the SP’s ID number, age and sex, technician ID number and the time the exam started, the time it was completed and the assigned status code. Three status codes are used for the Status Code column. Code (C) indicates a "completed" exam, (PC) indicates a "partial complete" exam, and (NE) indicates "no exam." (PC) and (NE) both require reasons for the assigned codes. The comments sections is used to note reasons why the examination was not completed (PC or NE), or any unusual occurrences, etc. The pages of the log are kept in a file until the end of the stand. At that time, the log pages are sent to Westat with the other end of stand materials.

4.3. Equipment Calibration Log

Daily equipment checks and calibrations of the anthropometric equipment are recorded in the Calibration Log (see Exhibit 4-2). As indicated in Section 2, skinfold calipers, the infant measuring board, the Toledo weight scale, and the Stadiometer all require daily checks before the first examination session each day. Calibrations are performed at the times indicated in this manual.

The technician performing the checks completes the top of the log sheet entering the stand number and location. The technician’s ID number is recorded and the date of the check or calibrations should be recorded in the appropriate boxes. Calibration Log sheets are kept until the end of the stand. At that time, they are mailed with other required materials.

4.4. Shipment of Forms and Logs

At the end of each stand and at designated times during the stand, all materials are mailed to either Westat or NCHS. A standard transmittal form is to accompany any mailing of these materials. Transmittal forms are generated from the automated system.

Always make a copy of the transmittal form to keep for your records as well as recording any pertinent information about the mailing procedure (e.g., time of mailing, post office from which you mailed). If the packet with completed forms is lost in the mail, this information will enable the packet to be traced and you will have a record of everything that was contained in the packet.

For the body measurement procedure, you will be mailing the following forms, logs, and data material:

• Body measurement daily log sheets,
• Equipment calibration log,
• Stadiometer calibration pictures,
• Toledo scale readings,
• Quality control for body measurements form,
• SP standing height and sitting height pictures, and
• Hardcopy exam forms (if used).

Detailed procedures for shipment of materials is discussed in the Standardized Procedures section.

Publication omitted

Curb JD, Ceria-Ulep CD, Rodriguez BL, Grove J, Guralnik J, Willcox BJ, Donlon TA, Masaki KH, Chen R. Performance-based measures of physical function for high-function populations. J Am Geriatr Soc. 2006 May;54(5):737-42. [PubMed ID: 16696737]

Framingham Heart Study

1/27/2009

This device is designed to measure the walking speed of a person over a fixed distance. It consists of two IR (infra-red) sensor boxes with companion reflectors and a central timer unit.

A diagram of the system is shown above. The two infrared (IR) sensors are placed on one side of the walking path pointing at right angle to the path. A reflector is mounted directly across from each sensor. A cable connects each sensor to the timer unit.

Mendoza JA, Zimmerman FJ, Christakis DA. Television viewing, computer use, obesity, and adiposity in US preschool children. Int J Behav Nutr Phys Act. 2007 Sep 25;4:44. [PubMed ID: 17894878], [ID : PMC2131753]

Publication omitted

Mohler ER. Peripheral arterial disease: identification and implications. Arch Intern Med. 2003 Oct 27;163(19):2306-14. [PubMed ID: 14581250]

Publication omitted

Salmon J, Owen N, Crawford D, Bauman A, Sallis JF. Physical activity and sedentary behavior: a population-based study of barriers, enjoyment, and preference. Health Psychol. 2003 Mar;22(2):178-88. [PubMed ID: 12683738]

Publication omitted

Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. [PubMed ID: 10568646]

Publication omitted

Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006 May;54(5):743-9. [PubMed ID: 16696738]

Publication omitted

Sugiyama T, Healy GN, Dunstan DW, Salmon J, Owen N. Is television viewing time a marker of a broader pattern of sedentary behavior? Ann Behav Med. 2008 Apr;35(2):245-50. [PubMed ID: 18357498]

Publication omitted

Wilson MM, Thomas DR, Rubenstein LZ, Chibnall JT, Anderson S, Baxi A, Diebold MR, Morley JE. Appetite assessment: simple appetite questionnaire predicts weight loss in community-dwelling adults and nursing home residents. Am J Clin Nutr. 2005 Nov;82(5):1074-81. [PubMed ID: 16280441]

An informed consent is administered to each participant by a trained interviewer prior to the collection of any research examination study data. The “consent form” is a two-part document. The first part is a narrative description of the studies goals, the content of the exam, the risks and benefits of participating, the confidentiality policies, the right to withdraw from the study, and what compensation is provided in the unlikely event that results in the need for medical care. The second part is the participants authorization page, which the participant signs. This documents the participant’s consent agreeing to (1) participate in an interview and clinical examination, (2) be contacted by study personnel in the future, (3) obtain medical records concerning information relevant to the study, (4) release their clinically relevant study data to their medical care provider, and (5) use of previously frozen blood samples for research. The documents core content complies with guidelines from the National Heart, Lung, and Blood Institute and is approved by BU Medical Center IRB.

Consent by Substituted Judgment (CSJ) will be obtained for Generation 3 cohort participants who are cognitively impaired. Participants who required CSJ at examination 1 will be identified prior to scheduling the appointment for examination 2 so that appropriate consent for the exam can be obtained. Participants who do not have any prior history of a cognitive impairment but are identified as having a change in cognitive status during the recruitment process will be discussed with the Framingham Study Neurology/Dementia investigators to make a determination about capacity to provide consent.

To obtain Consent by Substituted Judgment, a proxy (an immediate family member, legal guardian, or person with Power of Attorney) will be identified and contacted prior to the exam. This person will be informed of the exam content and asked to consent on the participant’s behalf. The CSJ form will be mailed to this contact to complete and return in a pre-paid FHS envelope. When this form has been returned, the exam can be scheduled. At the time of the first examination (2002-2005) all participants without a cognitive impairment were asked to provide the name of a proxy and an alternate so that if in the future he/she was unable to provide medical information and consent for research examinations his/her designated FHS proxy could do so.

If at any time during the examination a staff member believes there is a question of cognitive impairment the FHS clinic physician will evaluate the participant prior to further testing. If it is determined that a CSJ is needed the examination will be aborted until CSJ can be obtained.

When Consent by Substituted Judgment should be administered:

1. In cases where Cognitive Impairment is noted on the roster screen “Cog Imp”
2. In cases where the consent status is a “3, 4, or 5”
   • 3 = Likely to require consent by substituted judgment as well as own informed consent.
   • 4 = Incompetent to give informed consent; has legally appointed guardian and needs consent by substituted judgment.
   • 5 = Referred for assessment of competence to provide consent; status could not be determined.
3. At any time in the recruitment process, in the admitting process, or during the exam if there should be even the slightest question of cognitive impairment, steps should be taken to determine whether consent by substituted judgment is needed.

The HIPPA Privacy Rule, in effect April 14, 2003, protects the privacy of subject’s health information which is used in human research. For researchers to gain access to health information that is stored at any HIPPA “covered entity” investigators must provide the covered entity with written assurances covering how the health information will be used and protected.

The Framingham Heart Study is not a “covered entity”. However hospitals, nursing homes and physician offices from which the FHS collect medical records are covered by HIPPA rules. Therefore, in order for the FHS to retrieve medical records, participants must sign the HIPPA medical release form. If the participant chooses not to sign the form they will be able to participate in the exam but the FHS will not be able to obtain any outside medical records.

The following explanation of the form is to be given during the intake process:

We want to use your private health information in this research study. This will include both information we collect about you as part of this study as well as health information about you that is stored in your medical records. The law requires us to get your authorization (permission) before we can use your information or share it with others for research purposes. You can choose to sign or not sign this authorization. If you choose not to sign this authorization, you will still be able to take part in the research study.

The participant must also be given adequate time to read the release form. If they agree to sign the form, they must be given a copy of it with their signature. For offsite exams, a photocopy will be mailed with the Informed Consent to the participant.

For cognitively impaired participants: If the participant is cognitively impaired and have had their consent form waived, have the participants’ POA sign the HIPPA form and ask for copies of the POA documentation to go along with it. The POA documentation is necessary for medical records to obtain records from covered entities.

IRB Number: 1910G

Subject's Name: ____________________ Birth Date: _______________

We want to use your private health information in this research study. This will include both information we collect about you as part of this study as well as health information about you that is stored in your medical records. The law requires us to get your authorization (permission) before we can use your information or share it with others for research purposes. You can choose to sign or not to sign this authorization. If you choose not to sign this authorization, you will still be able to take part in the research study.

Participants Name / I.D :

Clinic Exam Date:

Second Appointment Date:

*Check Box to indicate which test(s) will be completed on the second visit.

* Maximum Time is with Albuterol Testing Only.

- Why did this participant leave early?

- Which Technician did this participant work with most?

- Recruiters Initials:

1. If a participant does not bring his/her appointment letter then the admitter should provide a blank form to be completed by the participant. The following information should be provided by the participant:
   1. Social security number
   2. Physician(s) if none please have them indicate none
   3. Brief medical history - Doctors visits etc. (to the best of your ability)
2. A name and ID label should be placed on the sheet and this sheet stamped with the exam date and placed in the chart.
3. MD Check box: If the participant does not have a doctor at the date of exam but plan to provide us with a name in the near future, please have them check the YES box.
4. The following document should be given to the participant in admitting:
   1. One consent form with a copy of the signature page administered by admitter.
   2. One copy of the HIPPA form with the signature page attached administered by the admitter.
   3. Optional one copy of the CT consent with the signature page attached administered by the admitter.

1. Give participant Consent Form to read, encourage and offer to help if there are any questions.
2. Check Consent for all boxes to be checked off, signature, name printed and correct date.
3. Check list of doctors on Consent Form against appointment letter.
4. Ask the participant if the listing of physicians being sent reports is complete.
5. Sign and print your name on appropriate line of Consent Form and date.
6. Explain the HIPPA form and ask them to sign the back page.
7. Copy the checkbox and signature pages of the consent and the back page of the HIPPA form.
8. Give the participant the photocopied pages for their records.

The Consent Form is administered in the Admitting Station at the time of the Clinic Exam. The participant is given the Consent Form and is instructed to read it carefully and to please check off the boxes on the last page, and date and sign it. If the participant has any questions regarding the Consent Form, they are encouraged to ask at this time. A duplicate copy of the Consent Form is given to the participant for his/her own records. Once the Consent has been read and signed it is reviewed by the person admitting, specifically checking for signature and that the boxes are checked. In the event that any of the boxes are checked “no, this should be reported to the Laboratory Director or the Patient Coordinator. The Consent should be place back in the chart with the signature page displayed.

Common questions that are generated are:

1. What is DNA used for?

   Answer: It is used for research to see which specific genes are linked to heart disease. Once those are identified, then the question remains, how do you turn those genes off to prevent heart disease.

2. What is a Cell Line?

   Answer: A Cell Line is a blood sample that is handled in a specific way to enable us to grow DNA forever.

3. Are you going to clone me?

   Answer: No.

4. Will I be able to get any results from the DNA?

   Answer: No, there will be no results from the DNA as the information is looked at as a group of information and not for the individual.

5. Are you going to sell my blood? I don’t want my information to go to a forprofit company.

   Answer: No we are not going to sell your blood.

6. How much blood are you taking?

   Answer: We take 12 tubes of blood which is 3 ½ ounces, which is less than onehalf cup of blood. When you give blood, they take one pint which is 2 cups of blood.

Dear___________________________:

We thank you for participating in the Framingham Heart Study. Your clinic appointment is scheduled for ___________at _____________.

The Framingham Heart Study’s address is 73 Mt. Wayte Avenue, in the Perini Building. The Framingham Heart Study offices are located in the wing at the Franklin Street side of the Building. There is reserved parking for participants behind the Franklin Street wing. Please see the enclosed map. The building is handicap accessible.

You should bring slippers and if you choose, bring your own robe. In order to perform certain tests, we ask that you NOT eat after 8:00 P.M. the previous evening. You may have water, decaffeinated black coffee or tea (no creamer, milk or sugar) that evening and again in the morning before your appointment. A urine sample will be collected when you arrive.

Please do not wear jewelry because of the Bone Density Scan.

Please take any prescription medications, as you normally would.

Using the enclosed MEDICATION BAG, please bring all prescription and nonprescription medications you currently take or have taken in the past month in their original containers.

ON THE BACK OF THIS SHEET, please list information regarding hospitalizations and major illnesses you have experienced since your last exam or health history with the Framingham Heart Study.

PLEASE BRING THIS LETTER WITH YOU TO THE CLINIC. If you need help completing this form, Clinic staff can assist you at the time of your appointment.

If you have any questions, please call, Project Coordinator at locally and for long distance at

Sincerely yours,

, MD
Director
Framingham Heart Study

OVER→

FHS REPORT GOES TO:

Hospitalizations, Emergency Room Visits, or Day Surgery Since Your Last Clinic Visit

Doctor Office Visits:

Hello Mr/Mrs. Blank

This is _________ from the FHS. I am calling to remind you of the appt you have with us on Monday, January 2 at 7:30 a.m.

Please be sure to read the appt letter. There is important information you need to know about before you come in.

Please bring a list of your brothers and sisters, names, addresses, telephone numbers and a date of birth for each, as well information about a contact person.

If you have any questions, please be sure to call us at or, the number that is listed on your appt letter.

Thank you for your participation in the Framingham Heart Study.

NOTE: DO NOT USE THE STATEMENT BELOW UNTIL IT IS DECIDED TO DO SO.

*** We know you are aware how important it is to keep this appt so that everyone who would like to be a part of this famous/important Study will have an opportunity to do so.

Participants Name / I.D. :

Clinic Exam Date:

Second Appointment Date:

*Check Box to indicate which test(s) will be completed on the second visit.

* Maximum Time is with Post Albuterol Testing Only.

- Why did this participant leave early?

- Which Technician did this participant work with most?

- Estimated time for testing by tech?

- Recruiters Initials:

If a participant returns after original consent date:

1. The participant should date and initial the consent page next to the test being done.
2. Someone will initial the page.
3. Someone will staple a dated note to the consent explaining what was done.

Gen3 exam 2

core exam components

May 2008

Blood samples are collected from an antecubital vein with participants in a supine position after a 12-hour fast. The following tubes are drawn.

• 5 x 10 ml lavender tops (EDTA)
• 1 x 15 ml red top (serum)
• 1 x 10 ml red top (serum)
• 1 x 4.5 ml blue top (citrate)
• 2 x 8.5 ml yellow top (ACD)
• 2 x 8 ml blue tiger top (CPT)

Total volume of blood drawn is 112.5 ml (3.8 ounces).

EDTA

1. EDTA plasma used for cholesterol, HDL cholesterol, triglycerides and glucose measured fresh at the Heart Study.
2. EDTA plasma sent to Tufts HNRC for other lipids.
3. EDTA plasma and red blood cells sent to Tufts HNRC for homocysteine, vitamins B6, B12 and folate.
4. EDTA plasma saved in several aliquots for future measurements. Stored at –80 C.
5. Buffy coat samples saved from all 5 EDTA Vacutainers. To be sent to Framingham Genetics Laboratory at Boston Medical Center for extraction of DNA.

Serum

1. Serum used for creatinine and uric acid, measured fresh at the Heart Study.
2. Serum saved in several aliquots for future measurements. Stored at –80 C.

Citrate

1. Citrate plasma saved for fibrinogen, stored at –80 C.
2. Citrate plasma saved in several aliquots for future measurements. Stored at –80 C.

ACD

ACD whole blood shipped twice weekly to Framingham Genetics Laboratory at Boston Medical Center. Used for extraction of DNA.

CPT

CPT whole blood shipped daily to Fairview University Medical Center in Minneapolis, Minnesota. Lymphocytes are cryopreserved in preparation for future immortalization.

Urine

As part of the Gen 3 Exam 2 clinic visit participants are asked to provide a random urine sample. Samples are tested for pH, protein, glucose, ketone and blood with reagent test strips. Urine save in several aliquots for future measurements. Store at –80 C.

1. Ask participant to wear FHS gown for measurement if he/she brought a heavy gown from home ask them to remove it. The participant should remove slippers or shoes.
2. Prior to asking participant to step onto the scale, if barefoot, put a piece of paper on the scales platform then lift the counter poise and position it at zero.
3. Ask the participant to step onto the scale, facing measurement beam.
4. Instruct the participant to stand in the middle of the scale platform with head erect and eyes looking straight ahead. Weight should be equally distributed on both feet and the participant should not touch or support him/herself.
5. With the participant standing still in the proper position lift the counterweight (larger weight) and slide it to the right until the beam approaches balance.
6. Adjust the top poise until the beam is evenly balanced.
7. Have the participant step off the scale. The technician should stand directly in front of the scale and read the weight with eyes level to the point of measurement.
8. Record the weight to the nearest pound; round up if ≥ 0.5, round down if < 0.5.
9. If a participant exceeds 400 lbs Code as 400 and write a comment at bottom of page. *This will not be coded as a protocol modification only a comment.*
10. If deviations from the protocol occur record it as a protocol modification.

1. The participant should remove slippers or shoes.
2. Prior to asking participant to step on the scale, if barefoot, put a piece of paper on scales platform then turn scale on and check to make sure it reads 0.0. The scale should be on a flat, hard surface.
3. Ask the participant to step onto the scale.
4. Instruct the participant to stand in the middle of the scale platform with head erect and eyes looking straight ahead. Weight should be equally distributed on both feet and the participant should not touch or support himself/herself.
5. Read the digital display while participant is on the scale.
6. Have the participant step off the scale.
7. Record the weight to the nearest pound; round up if ≥ 0.5, round down if < 0.5.
8. If a participant exceeds 350 lbs Code as 350 and write a comment at bottom of page. *This will not be coded as a protocol modification only a comment.*
9. If participant is unable to stand for weight measurement at a nursing home record the last weight in nursing home chart and the date the weight was obtained. If the participant is unable to stand on a scale during a home visit, record the weight measurement as 999.
10. Calibrate scale monthly with 50 lb. weight.

1. Participant should be wearing thin socks if barefoot, put a piece of paper on the floor under the stadiometer. Ask participant to stand erect with his/her back centered on the vertical mounted stadiometer.
2. Heels should be against the wall, both feet flat on the floor touching together with weight distributed evenly across both feet.
3. Check to make sure both heels are back against the wall.
4. Participant faces straight ahead with his/her head positioned in the Frankfort horizontal plane (see next page). The lower margin of the bony orbit (the socket containing the eye) should be on the same horizontal plane as the most forward point in the supratragal notch (the notch just above the anterior cartilaginous projections of the external ear).
5. Ask participant to let arms hang freely by the sides of the trunk, palms facing the thighs. Ask participant to inhale deeply and maintain a fully erect position.
6. Bring the level down snugly (but not tightly) on top of participant’s head.
7. Record measurement to the nearest 1/4 inch, rounding down.
8. If deviations from the protocol occur record it as a protocol modification.
9. If a participant exceeds 83.5 inches code as 83.5 and write a comment at bottom of page. *This will not be coded as a protocol modification only a comment.*

Standing Height Measurement

1. Participant stands erect, arms hanging loosely at sides, weight equally distributed on both feet, head positioned in the Frankfort horizontal plane.
2. Standing to face the left side of the participant, identify the thyroid cartilage by gentle palpation of the neck. Gently place your left index and second fingers on the front of the neck and ask the subject to swallow to help find the correct spot. You should feel a slight depression.
3. Place the superior border of the anthropometric tape just inferior to the laryngeal prominence.
4. Apply the tape snugly, but not tightly, perpendicular to the long axis of the neck, which is not necessarily in the horizontal plane at approximately a 90 degree angle.
5. Record the neck circumference to the nearest 1/4 inch, rounding down.
6. The pressure on the tape should be the minimum required to maintain skin contact.

Neck Girth

1. Participant stands erect, arms hanging loosely at sides, weight equally distributed on both feet, head facing straight ahead.
2. The technician will take the gown from the back and place it over the shoulder of the participant. The technician will ask the participant to bend their arms at the elbow and hold the gown in place.
3. Apply anthropometric tape at the level of the umbilicus.
4. Apply tape snugly but not tightly.
5. Make sure the tape is horizontal and not twisted, checking from both the front and back by using 2 mirrors mounted to the wall.
6. Before recording measurement ask the participant to fully relax their shoulders.
7. Record measurement to the nearest 1/4 inch, rounding down.

Waist Girth

1. Participant stands erect, arms hanging loosely at sides, feet together and weight equally distributed on both feet, facing straight ahead.
2. If the participant is wearing a gown, ask them to hold up their gown above their waist with their elbows relaxed by their sides.
3. The examiner stands on the participants left side and applies the measuring tape around the maximum extension of the buttocks (see figure on next page).
4. The examiner should be squatting or kneeling so that their eyes are at the level of the maximum extension of the buttocks.
5. Make sure the tape is horizontal and not twisted, checking from both the front and back by using 2 mirrors mounted on the wall.
6. The zero end of the tape is held under the measurement value.
7. Apply tape snugly but not tightly.
8. Record measurement to the nearest ¼ inch, rounding down.
9. If the participant is wearing baggy underpants then the examiner stands in back and gathers the side seams together and places the thumb in the fabric to make a fold.

Protocol from: National Health and Nutrition Examination Survey III – Body Measurements (Anthropometry)
http://www.cdc.gov/nchs/data/nhanes/nhanes3/cdrom/NCHS/MANUALS/ANTHRO.PDF

1. Ask the participant to lie supine on the examination table.
2. Inform them you will be performing an ECG and read the following script:

   An ECG is made up of waves showing the electrical activity in different parts of the heart. This new research test is an ECG that looks at a specific wave, the P wave, which shows activity in the top part of the heart. In order to get an accurate test please try to lie still. The test takes approximately 10 minutes.

3. Tell the participant you will be placing electrodes on their arms, legs, chest and back. Inform them you will be cleaning those areas with alcohol wipes as well as making marks on their chest with a cosmetic pencil.
4. Before electrodes are placed on the participant, ask if he/she is known to be allergic to alcohol wipes. If yes, prepare the areas of electrode placement by rubbing with water and drying with a washcloth. If allergies are denied, prepare areas V1, E, V2-V6, RL, RA, LL, LA, and I by wiping with a Tens Cote Cleaner. Let dry.
5. V2: The first intercostal space is palpated just below the clavicle. Count down and identify the 4th intercostal space just below the fourth rib. Point V2 is just to the left of the sternum in the fourth intercostal space. Make a small line with a marking pencil here to show where the ECG lead should be placed.
6. V1: Is at the same level as Point V2 and immediately to the right of the sternum. Make a small line with a marking pencil to show where the ECG lead should be placed.
7. E: To locate the horizontal reference level for electrodes (Point E), starting from V2, locate the fifth intercostal space. Move your finger in the 5th intercostal space laterally to where the midclavicular (center of the chest where you feel a bend in the clavicle) line intersects the fifth intercostal space. Make a horizontal line at this point.

   Mark the exact transverse (horizontal) level at this spot with the midsternal line. It should be about one inch (1”) below V1 and V2 placements. This is point E.

8. V6: Move the participant’s left elbow laterally away from the body. Mark the midaxillary line in the exact vertical center plane of the thorax down to the intersection of the horizontal plane marked by the location of E. This is the exact location of V6. (NOTE: It is a common mistake to locate the midaxillary line too far anteriorly, toward the V5 location).
9. V4: Place the # arm of the Heart Square firmly across the lower sternum at the level of Point E (as you face the participant, the writing on the Heart Square will appear upside down and backwards). Adjust the E and V6 arms of the Heart Square so they are both perpendicular to the long axis of the thoracic spine at the level of the E position. The E arm should be exactly horizontal. If the participant is lying flat, the V6 arm should be exactly vertical.

   Slide the V6 arm so the 0 point (the arrow labeled V6) is at the marked location for V6. Double check that the E arm is still in the correct spot.

   On the V6 arm (the slide) find the number corresponding to the E measurement. Following the corresponding 45 degree line to the surface (e.g. 16) and mark the location following the inside of the square. This is point V4. Make mark on TOP of the breast. Note: For women with smaller breasts the measurements may land directly below the breast tissue.

   The participant may now place their left arm in a more comfortable position next to their body.

10. V3: Exactly halfway between V2 and V4.
11. V5: Exactly halfway between V4 and V6.
12. I: While standing on the participant’s right side move the participant’s right elbow laterally away from the body. Mark the midaxillary line in the exact vertical center plane of the thorax down to the intersection of the horizontal plane marked by the location of E. This is the exact location of I.

    The participant may now place their right arm in a more comfortable position next to their body.

13. Place the electrodes on the participant in the following order: LA, LL, RA, RL, V1, E, V2-V6, I, H, M. The body of the electrode is placed centrally at the pencil mark with the tab extending downward on the body.

    Leg leads should be placed on the calf midway between the knee and ankle. If the participant has an amputation, the lead should be placed above this. The limb leads are placed on the body so the silver tab is facing outward.

14. Place the Acquisition Module on the participants lap and ask them to hold it. Separate the leadwires. While holding wires 1 and 4 (the two longest wires) ask the participant to sit up. Move robe to expose the participant’s back. Be sure to keep the participants chest as covered as possible
15. Ask the participant to sit up straight and prepare the skin by cleaning areas H and M with a Tens Cote Cleaner.
16. Place electrode H on the back of neck tab facing downward, on the bony prominence. If necessary, have the participant put his/her head forward to identify the bony prominence
17. Place electrode M at the center of spine tab facing downward, on the same horizontal level as lead E.
18. Connect leads H and M
19. Bring the wires over the participants left shoulder and ask the participant to lie down. Make sure the lead connections are not disrupted.
20. The remaining leads should be connected in the following order: LA, LL, RA, RL, V1-V6, E, I
    

21. Ask the participant to lie still and relax. In the computer, enter the participants Name, ID, Age, Height, Weight, and Gender. Enter the Exam Cycle, Location (1=clinic) and Technician ID Number.

    Note: When entering Height and Weight round up if the weight is ≥.5 or ≥ .50 for height.

22. Double check that all leads are connected properly.
23. Offer to cover the participant with a blanket or their robe. Note: If the participant is cold this could interfere with the quality of the ECG.
24. When a quality ECG is displayed on the computer screen hit ECG to store.
25. The ECG is reviewed and printed for errors
26. Verify ECG Data Storage to Mac 5000
    1. Press File Manager
    2. Highlight the Participants Name
    3. Press Display
    4. View and Verify the Participants Name and ECG Recording
    5. If ECG needs to be run at 5 mmHg because of high voltage (if the standard 10 mmHg is beyond the lines of the ECG paper), highlight (yellow or orange highlighter) the 5 mmHg on the bottom of the printed ECG. On the top margin of the tracing write “1/2 STANDARD” using a bold magic marker.
27. After the completion of the standard ECG again ask the participant to lay quietly and still during the acquisition of signal to decrease noise. Turn off the lights.
28. Begin the ECG P Hi Res by following the steps below in the computer:

    Hit Main → More → More (to get to P Hi-Res). Do NOT select Hi-Res.
    Same patient
    Press TEMPLATE
    Computer responds that it is acquiring template data and prints it out.
    Press AVERAGE
    After 250 beats have been averaged the acquisition will end.
    Press STORE

29. Leads are checked again for proper placement and disconnected after all leads are checked. Electrodes are carefully removed.
30. Click back on the Main Menu and next on Resting ECG. When it asks you if you want to use the information for the last participant hit no. The machine will be ready for the next participant.
31. Stamp both standard ECG and P Hi-Res ECG with #2.
32. Place standard ECG in participant’s file for MD to review during exam.
33. Place paper copy of P Hi-Res ECG in folder in room.

Parameters: Keep on 250 qualified beats.

During testing keep noise level less than 1 mv (if possible) it is normal for the noise to start out high and then diminish during the averaging process.

Do not change the QRS complexes settings.

When and how to abort test:

A decision not to complete the test may be made when a participant has:

• 1=atrial fibrillation
• 2=paced rhythm
• 3=frequent PVCs or APCs
• 4=tremor

If the P Hi-Res ECG runs more than 10 minutes abort the test.

Computer instructions to abort test:

• Patient data
• Template
• Prints it
• Average
• Press “Pause” to abort test.
• STORE

If you press Pause by mistake, then press Resume.

Troubleshooting Tips

Adapted from Clinical Education and Development. MAC 5000 Resting ECG Analysis System Clinical Reference Guide, 030-CARD-MAC5000MT, Part No. 2015231-006

The float staff member’s responsibility:

1. Put the chart in order & check the chart for completeness.
2. Using the Procedure Sheet on the back of the Numerical Data Sheet confirm that everything has been completed.
3. Complete the top portion of the Procedure Sheet by filling in the number 1 when something has been done.
4. If anything is missing flag the chart and make sure the procedure is completed prior to the participant having an exit interview.
5. Put the Numerical Data Sheet and the Referral Tracking Form sticking sideways out of the chart in the correct order and obtain a button.

During the exit interview (all staff):

1. Check the referral tracking sheet (complete with your ID number and any adverse events in clinic) and review with the participant any referral recommendations.
2. Confirm with the participant that they have completed their Food Frequency Questionnaire and have given it to a FHS staff member.
3. Ask for feedback from the participant on how they felt about their examination.
4. Write in any comments that are made.
5. Make sure the participant leaves the clinic area with all of their belongings; ESPECIALLY THEIR MEDICATION BAG WITH MEDICATIONS.
6. Thank the participant for their time and willingness to participate.
7. Remember that this is a very short Interview and should go no longer than 5 minutes.

NOTE: The chart does not have to be put in order to do an exit interview. If the clinic is busy and someone is unable to put it in order prior to the exit interview proceed as follows:

1. Take the Numerical Data Sheet, Questionnaire packet & Referral tracking sheet in with you during the exit interview.
2. Review with the participant that each procedure has been completed.
3. Complete the top portion of the Procedure Sheet by filling in the number 1 when something has been done.
4. Check the referral tracking sheet (complete with your ID number and any adverse events in clinic) and review with the participant any referral recommendations.
5. Confirm with the participant that they have completed their Food Frequency Questionnaire and have given it to a FHS staff member.
6. Ask for feedback from the participant on how they felt about their examination.
7. Write in any comments that are made.
8. Make sure the participant leaves the clinic area with all of their belongings; ESPECIALLY THEIR MEDICATION BAG WITH MEDICATIONS.
9. Thank the participant for their time and willingness to participate
10. Put the chart in order before it goes upstairs

COMMONLY ASKED QUESTIONS

Q. When will you call me back for my next exam?
A. We can’t say for sure right now. Investigators will begin planning for future exams as our current research contract with NHLBI is completed.

Q. What will be in my report and when will I get it?
A. You will receive your report in roughly 4-6 weeks. Your report will have results of your blood work, your blood pressures, and a general statement from the physician who saw you.

After the clinic staff is finished with the participant’s charts for the day the charts are sent upstairs to the Statistical Technician. The Statistical Technician then proceeds as follows:

1. The physician’s letter and the ankle arm blood pressure is typed.
2. The consent form, cancer pages, the ECG, and the participant’s letter are photocopied.
3. The exam is reviewed for any blanks or inconsistencies.
4. Events are flagged for Medical Records.
5. After editing is complete the chart waits for Dr. or Dr. to sign the physician letter.
6. Once the letter is signed, the chart is put in a file drawer to wait for the lab results, PFT, and ECG card.
7. Once all results are received, the physician letter with lab results, PFT, ECG, and ankle arm blood pressure, and the participant’s letter with lab results and ECG card are mailed.
8. After the mailing, the chart goes to keying.
9. Once the chart has been double keyed, it returns to the Statistical Technician to check off that it has been keyed.
10. It then goes off to Medical Records for processing.

Instruction manual omitted -- Copyright © 2008 Respironics, Inc. and its affiliates. All rights reserved.

06/10/08

Training slides omitted -- prepared by Respironics

We are asking everyone in your generation to wear this new device called an accelerometer which will capture you movement. We would like you to wear this device for 8 days, 24 hours a day. It is very small and will be attached to a belt worn around your waist. You may wear the belt over or under your clothing which ever is more comfortable for you. Is this something you are willing to do for the Framingham Heart Study?

(If yes)

Great! I will show you how to wear the belt and then you can put it on for me.

(Demonstrate and use the picture from the handout as a visual then watch them put it on.)

Here is an information sheet for you to take home. The only time you will be taking the belt off is when you shower. The device is waterproof but we are not asking anyone to wear it while showering.

Are you going to be going swimming or doing any water sports while wearing it? (If yes, give a second belt.)

Once you are done wearing the device place it into the return envelope sealed in the bubble bag with the belt.

Please put the device in the mail immediately after taking it off. We need these devices for the next participants that are coming in. Because these devices are expensive, we cannot keep a lot in stock.

Please read the instructions when you get home. There are some common questions on the back of the first page as well. If you have any questions or concerns just call (point out on sheet). Thank you very much.

(If No or hesitant)

Okay, would you be willing to just try it?

If a definite no then write in the Comments box an explanation as to why.

Please read carefully:

1. Wear the device for 8 days / 24 hours a day.
2. Do NOT wear in the Shower (remember to put the device back on once you get out of the shower).
3. Wear the device while sleeping.
4. The device will be worn over the right hip resting on the iliac crest (Do NOT change sides).
5. The device should be snug against the body but not tight.
6. It can be worn underneath or on top of clothing.
7. You may engage in activities that you normally do.
8. Please return device and belt in the bubble pouch located inside the white return folder and write us any feedback you may have about your experience wearing the device.

You may take off the activity monitor and send it back in the return envelope given to you at your exam on: _______________

(Take off around 3 p.m.)

PLEASE RETURN THE DEVICE EVEN IF YOU ARE NOT ABLE TO WEAR IT FOR 8 DAYS. THE DEVICES ARE EXPENSIVE & FAILURE TO RETURN THE DEVICE MAY PROHIBIT FHS FROM COMPLETING THIS STUDY. AS ALWAYS, WE THANK YOU FOR YOUR PARTICIPATION.

FAQ

The belt should be mounted on the body so that the Actical device rests on the iliac crest of the hip. The iliac crest is the uppermost and widest of the three bones constituting either of the lateral halves of the pelvis.

Proper hip mount

If you have any feedback about the accelerometer, please note it below and return it with your accelerometer.

Thank you again for your participation.

If you have any feedback about the accelerometer, please note it below and return it with your accelerometer.

Thank you again for your participation.

Publication omitted

Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. [PubMed ID: 16055882]

Spirometry Quality Control Program

FHS Third Generation Cohort - Examination 2

Review as of March 29, 2010

Publication omitted

Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. [PubMed ID: 9872837]

Read all prompts

• Minimize RaptorPlus (Patient Information)
• Shortcut to CPL
• Component = CPL
• Balloon check: check all boxes and click on Inflate
• Deflate

LEAK TEST

Put round weight on bell

• Leak Test
• Component = CPL
• S Delay = 20
• Duration = 60
• Start
• < -10 is ok. CANNOT HAVE ≥ -10. IF DO, REDO CALIBRATION

TOOLS (under RaptorPlus)

• (Follow prompts)
• Calibration
• *CPL (click on “+”)
• Barometric pressure (highlight and make drop-downs visible)
• Calibrate
• Calibrate
• Temp (leave temp that is shown on screen = machine temp)
• Enter
• Barometric pressure (leave barometric press that is shown on screen)
• Enter
• Continue

SPIROMETER

• Calibrate
• Calibrate (bell goes up)
• Attach syringe
• Press space bar
• Pull out syringe at constant pace
• Press space bar
• Push in at constant pace
• Press space bar
• All lines should have a green square = Valid. If not, repeat calibration
• Continue

PNEUMOTAC

• Calibrate
• Calibrate
• Continue
• Continue
• Press space bar
• Pull out syringe
• Press space bar
• Press space bar
• Push in syringe (push in before “4”)
• Space bar
• Continue
• Verify
• Close

Take off syringe

DL GAS ANALYZER

• Calibrate
• Next (all must be “Valid” in green)
• Next
• If “Failed” repeat DL Gas calibration ONLY
• If “Passed” press Finish

REPORT

• Check all boxes EXCEPT MOUTH PRESSURE
• Print
• Write initials at bottom of report
• Put printouts in white binder on low shelf in front of scale

END

• Minimize RaptorPlus
• Shortcut to CPL
• Component = CPL
• Close
• Enlarge Raptor

****On Fridays, please switch Collins to Nahanes (see instructions on wall below bulletin board)

FRAMINGHAM HEART STUDY

Pulmonary Function Testing

MANUAL OF PROCEDURES FOR GENERATION 3 EXAMINATION 2

Date: 4/1/09

10. Participant testing – detailed procedures

a. Exclusion criteria

Prior to all tests, the technician must ask the participant about pulmonary function testing exclusion criteria:

• Any of the following within 3 months: major surgery (chest, abdominal or brain), oral surgery, a heart attack, a stroke, or an aneurysm of the brain. If the participant has an aneurysm, ask where it is.
• Blood pressure today greater than or equal to 210/110. Check with the MD in clinic for the participant’s blood pressure reading. If the MD has not yet obtained a reading, take the participant’s blood pressure according to FHS protocol. If either the systolic or diastolic exceeds this limit, do not perform the PFT.
• Ask: Do you currently have any limitations on physical activity prescribed by your doctor? If the participant answers yes to this question the technician will discuss the limitation with the clinic physician. If the clinic physician determines the limitation will not be detrimental to the participant’s health if they perform the PFT, the PFT will be performed per protocol. If the limitation puts their health at risk if they perform the PFT the exam will be aborted and notes will be put in the computer.

On the following page is a flyer that should be printed out and placed on the wall at the pulmonary function testing station to remind the technician to ask about these exclusion criteria.

(To be placed in PFT testing room)

IN THE PAST 3 MONTHS HAVE YOU HAD:

• MAJOR SURGERY (Chest, abdominal, or brain, requiring hospitalization)?
• HEART ATTACK
• STROKE
• ANEURYSM OF THE BRAIN

IN THE PAST 1 MONTH HAVE YOU HAD:

• ORAL SURGERY (Surgery requiring tooth extraction, stitches, anything that can cause dry sockets)

DURING TODAY’S CLINIC EXAMINATION:

• BP ≥ 210/110 (Participant’s blood pressure MUST be taken prior to PFT Testing following the FHS protocol)

DO YOU CURRENTLY HAVE ANY LIMITATION ON PHYSICAL ACTIVITY PRESCRIBED BY YOUR DOCTOR? If YES~ STOP & Discuss with clinic MD

Note: Participants with chronic atrial fibrillation should not be excluded unless requested by participant.

b. Entering participant information

From the Windows desktop, double click on the “Plus 2000 Version 4.8” icon. On the Patient Information Screen tool bar click Search. Once the Patient Search box pops up enter the participant’s FHS ID Number and click search. Once the computer finds the participants information it will display on the right side of the search box. Click on the participant’s ID and hit Add to Cache. Close the search box and confirm that this is the correct participant (verify date of birth). Once this is confirmed click New Study. Update the participants Height & Weight and enter the tech number that is performing the test. Once the information card is appropriately completed, click on “Save” which will put the participant’s information in the “Cache” as seen in the navigation bar (top of the screen, next to “Notes”).

• Date - Before you update the information for the New Study, the computer will ask you (in a pop-up screen) for a date of the pulmonary function test- ensure that the date is correct.
• Name – If the participant’s name is not in all capital letters, retype the participant’s name. Enter the participant’s first name, tab to the next field then his last name. Use all capital letters.
• Date of birth -Confirm DOB
• Height - Enter the participant’s measured standing height in inches (including .25- .75)
• Weight – Enter the participant’s weight in pounds
• Gender - Does not need to be changed from exam 1
• Race - Does not need to be changed from exam 1
• Editing - If a mistake was made when entering information, use mouse to move the cursor to the error. Then begin typing the information.
• Saving the information - Once the data is satisfactorily entered, click on “Save.”

c. Spirometry

The technician is the critical part of the pulmonary function testing system, since the technician must guide the participant through breathing maneuvers that are highly dependent on participant effort. The technician must coach the participant to inhale maximally and then to exhale maximally and as rapidly as possible. The technician must also judge the quality of the participant’s effort. To obtain accurate results, the testing must be done in a standardized fashion.

Note: This manual refers to the participant as “he” or “him” for easy reading, although participants will be both male and female.

Position the Participant – Testing should be conducted in the sitting position in a chair without wheels. The participant should sit erect with chin slightly elevated.

Explain the Procedure – The technician should explain that the purpose of the next test is to determine how hard and fast he can exhale air, “Like blowing out dozens of candles on a birthday cake.” The technician should explain that he should take in as deep a breath as possible, and when his lungs are completely full, blow out all the air as hard and fast as possible, until told to stop.

Dentures, if they are loose, should be removed and placed in a clean cup, since they will prevent a tight seal from being formed around the mouthpiece. If dentures are not loose, leave them in place.

Always Demonstrate the Maneuver. The technician should ask the participant to watch them demonstrate the FVC maneuver. Again demonstrate correct placement of the mouthpiece. If the participant does not adjust well to using the mouthpiece (i.e. strong gag reflex) the participant can use just the neck of the filter for a mouthpiece. His lips must remain tightly sealed using this also. The technician should sit up straight. Take a deep breath, throw back their shoulders, and widen their eyes to emphasize the maximal depth of inhalation. Then dramatically BLAST out all of their air as hard and as fast as they can.

The technician’s vigorous demonstration will prevent time and effort from being wasted on unacceptable forced expiratory efforts that result from the participant’s failure to understand a verbal explanation of the procedure.

FVC Maneuver Test Steps

The technician should do the following:

1. To begin doing the maneuvers, click on “Go to,” then on “Forced Vital Capacity.” This will bring up the testing page.
2. Ensure that the participant has a clean filter and mouthpiece, but do not connect the participant until prompted by the computer. Click on “Start test.”
3. The spirometer will fill the bell and prompt the technician- THEN have the participant connect to the mouthpiece and breathe normally.
4. Ensure that the participant has a nose clip in place. If the nose clip is uncomfortable for a participant, then instruct the participant to tightly pinch his nostrils shut throughout each maneuver.
5. Once the participant is connected to the spirometer, nose clip in place, and is breathing normally, press the space bar. This will prompt the computer to track the regular breathing of the participant.
6. Once you are both ready, instruct the participant take in as deep a breath as possible and press the space bar while they are inspiring.
7. Coach the participant through the FVC maneuver, encouraging him to blow out as hard as possible for at least 6 seconds (as seen at the red vertical line on the time axis on the screen) and until the red line tracking the participant’s maneuver (on the right hand graph) becomes flat. Watch the participant inspire deeply and then shout “BLAST OUT!!!” Lower your voice a bit and coach the participant by saying “keep going…keep on pushing out all that air…a little bit more…”
8. Watch the body language of the participant as he attempts to follow your instructions. Pay attention to him, not the instrument.
9. Once he has “pushed” for at least six seconds and the participant tracking line has become flat and the “Good Effort” message appears over graph, push the space bar again to end the test, have the participant come off the mouthpiece, remove the nose clip and breathe normally.

Example Graph of the Spirometry Maneuver:

To summarize the testing process:

• Once the participant is connected to the spirometer with a nose clip on, push the space bar.
• After a couple of normal breaths, have the participant take as deep a breath as possible.
• While the participant is inspiring, press the space bar.
• As soon as the participant has reached maximal inspiration, have him blast out all the air in their lungs.
• Once he has blown out for at least 6 seconds and the graph of his breathing has become flat and you see the “Good Effort” message, push the spacebar to end the test.

The quality of the effort is seen at the top of the right hand graph- the quality is graded on (1) the initial effort (Extrapolated Volume, or EV), (2) flatness of the line or reaching of RV, Residual Volume, (End of Test, as defined by flow of less than 30mL/sec, or EOT), and (3) total expiratory time (TET).

You can repeat testing by starting again (with the participant off the mouthpiece initially) by going back to #2.

If the participant fails to perform the maneuver correctly, again demonstrate both the error and the correct performance yourself. You may have to repeat the demonstration after every maneuver for some participants.

The participant will be coached to perform at least 3 FVC maneuvers and to perform additional maneuvers, up to a maximum of 8, until acceptability and reproducibility goals are met, as described below.

FVC Maneuver Acceptability

According to the ATS standards, the technician should coach every participant to obtain at least three maneuvers that are “acceptable.” FHS uses current ATS standards to determine acceptability. For each FVC maneuver, the Collins CPL system displays a “+” or a “-“ to indicate whether each of three acceptability criteria have been met. These acceptability criteria are:

• Extrapolated volume (EV): “+” = EV less than or equal to 0.15 L
• Total exhalation time (TET): “+” = TET 6 seconds or greater
• End of test criteria (EOT): “+” = expiratory flow is close to zero (less than 30 mL/sec), i.e. the plateau on the volume-time curve appears flat

To be considered acceptable, all three criteria must be met, i.e. three “+” signs (which will appear in green) must appear for the maneuver. If one of more criteria receives a “-“ sign (in which case they will appear in red), the maneuver will be considered unacceptable. There will be two exceptions to this rule:

1. Some tall people can meet the alternative EV acceptability criterion of < 5% of FVC but not the criterion of ≤ 0.15 L. If a tall subject consistently does maneuvers that appear to be perfect but have an EV that just over 0.15L but less than 5% of FVC, then these maneuvers will be considered acceptable. This should apply to a small minority of subjects.
2. Some people with significant airflow obstruction cannot reach the EOT criterion of a flat plateau on the volume-time curve within a reasonable exhalation time that avoids substantial discomfort and a risk of dizziness or even fainting. For this reason, any FVC maneuver that appears otherwise perfect but fails to reach meet the EOT criterion despite a TET of 12 seconds or greater will be considered acceptable.

Reproducibility goal of the test session

The technician should coach every participant to obtain at least three maneuvers that are “acceptable,” as defined above. Once three acceptable maneuvers have been performed, the technician must assess whether the reproducibility goal has been met. The reproducibility goal has two components:

1. The two largest values of FVC must be within 0.150 L of each other
2. The two largest values of FEV1 must be within 0.150 L of each other

Note that the largest FVC and the largest FEV1 may come from different maneuvers. If the reproducibility goal is met by the three acceptable maneuvers, then the test session is complete. If the reproducibility goal is not met, then additional maneuvers should be performed, up to a maximum of 8, until the reproducibility goal is met. Remember that ONLY acceptable maneuvers should be considered when assessing whether the reproducibility goal has been met. Also remember that the reproducibility goal requires that the largest two values (not any two values) of FVC or FEV1 be within 0.150 L of each other.

Maximum Number of Maneuvers

Don’t exhaust the participant by asking him to perform more than eight FVC maneuvers. If you haven’t obtained 3 acceptable maneuvers and met the reproducibility goal by the time you have done 8 maneuvers, it is unlikely that you will. Click on “Notes” which will bring you to a screen where you may add comments as to why the participant was not able to successfully complete testing.

Saving the Results

Once you have obtained three acceptable maneuvers and have met the reproducibility goal (or failed to do so after 8 tries and documented the why in the “notes” field), testing is complete. Now click on “Save.”

d. Diffusion capacity

Setting up

After completing the FVC maneuvers-

• Click on “Go to”
• Click on “Diffusion Capacity”
• Click on “START TEST”

Preparing the participant

While the machine prepares, explain to the participant that he will be asked to breathe normally and then to blow all his air out, just like the Vital Capacity maneuver. Once his lungs are as empty as possible, the participant will be asked to breathe in as deeply and quickly as possible and hold his breath for 10-12 seconds. The machine will close a valve, helping him to hold his breath and making it impossible for air to leak out- he will not be able to breathe while on the mouthpiece until the tester tells the participant to blow all his air out for the second time.

Starting the Test

1. You will get a series of messages as the machine prepares. The machine includes the volume of the filter in the calculations.
2. The computer will then display the following message- “OK.” Click OK and then once the next box pops up, have the participant connect to the mouthpiece. “Press the spacebar when the patient is connected to the mouthpiece and breathing normally.” Ensure that the participant’s lips are tightly sealed around the mouthpiece and that the nose clip is in place. Once the participant is attached and breathing normally, press the spacebar.
3. The graph will show the participant’s tidal breathing. Once the participant is comfortable, have him breathe all the way out to Vital Capacity (the point at which the graph of his breathing becomes flat). Coach him, saying “Push, push, push” just as you would for the spirometry.
4. Once he has pushed all the air out, press the spacebar and IMMEDIATELY instruct him to take as deep an inspiration as possible. Ideally, the deep inspiration should take one to two seconds.
5. Once the graph of his breath has flattened out again at maximal inspiration, tell him to hold his breath.
6. Push the “V” key, as soon as his breath has flattened out at maximal inspiration, to close the valve and keep air from escaping. He must hold his breath for 10-12 seconds for the maneuver.
7. Once the participant’s graph crosses the vertical line on the screen, IMMEDIATELY instruct him to blow out all the air (if you closed the valve, it will open automatically at 12 seconds), just as though he was performing spirometry.
8. Have the participant keep blowing until the red line becomes horizontal.
9. Once the red line is horizontal, press the spacebar, ending the test.
10. After each diffusion hit save and go back to FVC to deflate the balloons.

To summarize-

• Once in the Diffusion Capacity menu, Click on “Start Test” and prepare the participant
• Once the machine is set up and you clicked ok, ensure that the participant is comfortable on the mouthpiece, with a good seal, and with a nose-clip in place.
• Press the spacebar.
• After several breaths, have the participant blow out all the air he can.
• Once the graph flattens out horizontally, push the spacebar, then IMMEDIATELY have him breathe in as deeply and quickly as possible and hold his breath.
• Once the participant has taken as deep a breath as possible and the graph flattens out again, push the “V” key to keep him from breathing out.
• When the graph of the participant’s breath hold crosses the vertical line, IMMEDIATELY have him blow out all the air he can, much like with the spirometry maneuvers.
• Once the graph flattens out at maximal expiration, push the spacebar, ending the test.

Grading the Test

The screen will change, and the effort is graded at the top of the graph on the left. Three criteria are applied- Start of Test (SOT), Breath holding Time (BHT), and End of Test (EOT). If all three are acceptable, they will be displayed in green. If one criterion is not met, then all three appear in red. The failed criterion will have a (-) sign next to it. Review how to improve this result with the participant.

As with spirometry, maneuvers must be reproducible. For DLCO, two acceptable (all green effort marks) maneuvers must be within 10% of each other (i.e. 10% of the higher value).

Per ATS standards allow 4 minutes between tests. Note that the machine takes several minutes to set up. Use the clock on the computer to time the 4 minutes.

Repeat the maneuver from “Starting the Test” until you have two acceptable and reproducible maneuvers.

Limit the number of attempts for DLCO to 3 per participant.

Example Graph of the DICO Maneuver:

e. Respiratory questionnaire administration

The technician administers this questionnaire to the participant between the first and second diffusion maneuvers. Machine preparation for the second diffusion capacity maneuver should be started before the questionnaire is administered.

The questionnaire must be administered exactly as written. The answers are recorded in numbers, as indicated in the answer keys to the right of the questions. The technician follows the prompts on the questionnaire for the progression to follow, based on ‘Yes’, (“if yes fill in …”) and ‘No’ responses.

If a participant reports that he/she uses an inhaler “as needed” and it was last used more than 48 hours ago, code as 88.

f. Bronchodilator administration and post-bronchodilator spirometry

1. Subject selection

   The selection of subjects who will undergo bronchodilator administration and postbronchodilator spirometry is described earlier in section 4. Briefly, all participants whose current pre-bronchodilator spirometry has EITHER a FEV1-to-FVC ratio less than 90 % of the predicted value OR a FEV1 less than 85 % of the predicted value will be asked to undergo post-bronchodilator testing.

2. Bronchodilator administration
   1. Albuterol information- We will administer 2 inhalations of albuterol HFA metered-dose inhaler 90 micrograms per actuation. Albuterol is a medication usually used to treat breathing problems like asthma or chronic obstructive pulmonary disease (COPD). The effects of albuterol last 3-4 hours. Participants with a history of adverse reactions to albuterol should not undergo this part of the protocol. At the doses we are using for FHS, only a small minority of participants would be expected to have side effects, and these side effects are listed in the “Consent Form.” The side effects include: lightheadedness, an increase in heart rate (pulse) or symptoms of jitteriness or shakiness (tremors).
   2. The administration of the albuterol will not take place until the participant has completed all other components of the exam. This will ensure that no other data will be affected by the possible side effects of albuterol.
   3. The participant will inhale two puffs of albuterol through a spacer. You should allow the participant to breathe normally for about a minute between inhalations, and there should be no less than 10 minutes and no more than 15 minutes between the administration of albuterol and the post-albuterol spirometry.
   4. Detailed step-by-step protocol for bronchodilator administration:
      1. Take the cap off the inhaler.
      2. Shake the inhaler.
      3. After shaking the inhaler, activate the inhaler in the air to check that it is operating adequately. Do this at arm’s length from the technician and not near a participant, such that neither technician nor participants inhales it.(Note: When a new inhaler is being used for the first time, or if an inhaler has not been used for 2 weeks, activate 4 times before testing the first participant.)
      4. Attach the inhaler to one end of a tube spacer. (Note: Each tube spacer, which is disposable and for single participant use, is a 6-inch length of segmented tubing cut from a 100-foot roll.)
      5. Have the participant breathe all the way out in a relaxed manner; there is no need to reach maximal exhalation (residual volume) by forcing out the maximum amount of air possible.
      6. Insert just the tip of the spacer into the participant’s mouth.
      7. Have the participant start to take a slow, deep breath in.
      8. Just as the participant starts to inhale, activate the inhaler once while encouraging the participant to keep inhaling all the way until he/she has reached the point of maximal inhalation (total lung capacity).
      9. At that point of maximum inhalation, have the participant hold his/her breath for about 10 seconds. After this, instruct the participant to exhale normally and relax.
      10. Wait 30 seconds and repeat for another inhalation.
      11. Following the second inhalation of albuterol, allow at least 10 minutes and no more than 15 minutes before doing post-bronchodilator spirometry.

g. Data Procedures after Participant Testing

Inserting Test Comments

At the end of testing, you may wish to insert comments regarding the ability of the participant to comply with testing. This is added at the end of testing, under the “Reports” menu.

1. Click on “Notes”
2. Type in your comments
3. Save & close

“Notes” Option

There is a tab on the upper left portion of the “Patient Information” page. If the technician has a comment regarding a participant that may be helpful for clinical interpretation (e.g. “patient having pain with deep breath due to bruised ribs after fall yesterday”) or for quality review (“e.g. patient refused to go on after two efforts”), then this should be entered under “Technician Notes,” followed by clicking “Save and Exit.”

Examples of notes that should be put in computer:

• Reasons for unacceptable tests
• Reasons for aborted tests
• Refusals
• Physical symptoms affecting performance of PFT

Printing Reports

The PFT report is printed after the test is reviewed and graded by a FHS physician (pulmonologist). After grading the test, this physician will select the “File” tab and click on “Print Report”. The HP Deskjet 845c. is selected and 1 copy is printed.

Log Book

All participants are entered into the “PFT Daily Log, Comment, and Calibration” binder. Enter, by date, each participant name. An FHS generated sticker with the name and ID number can be used. An *A* is placed next to the name and sticker of all albuterol challenge participants (both pre-identified and clinic identified).

Participants Completing the PFT

Once the PFT is done, a white sheet labeled “PFT” is completed by attaching a participant label, writing the date onto the sheet and filing it in the participant’s chart.

Participants Not Having a PFT

Participants not having a PFT during their Clinic visit are also put in the “PFT Daily Log, Comment and Calibration” binder with the reason that the PFT was not done.

A sheet labeled “PARTICIPANT DID NOT HAVE PULMONARY FUNCTION TEST” is completed by selecting the appropriate reason that the participant did not have the PFT. The date and participant label are entered onto the sheet and the sheet is filed in the participant’s chart.

Participants Refusing Bronchodilator Response Testing

Occasionally a participant who is asked to participate in the post-bronchodilator test refuses to do so. This refusal is recorded next to the participant’s identifying sticker in the PFT Daily Log Book and the refusal reason is also noted under “technician notes” in the computer. Before the participant is asked to change and exited from the clinic, a second technician should ask the participant if he/she might be willing to perform the bronchodilator response testing. If the participant refuses a second time, the technician will also add the participant’s sticker, the date and the refusal reason to the sheet titled “ALBUTEROL REFUSALS”.

Participant and MD Notification – PFT

Once a week the FHS pulmonary specialist comes into FHS and interprets with pulmonary function tests performed in clinic. He types a clinical interpretation on the participant’s report and prints and signs one copy. He then delivers them to the Research Clinic Coordinator. The Research Clinic Coordinator makes a copy of each of the reports and gives them to the Statistical Technician.

The Statistical Technician files the original copy in the participant’s chart and the second copy is mailed to the participant’s physician.

Moving PFT studies from one participant ID to another

For incorrectly entered ID numbers:

*Pull up the participant information by using the incorrect ID number and add to cache.

*Then, enter the correct number and fill in all of the correct information. (name, birth date, height, weight, technician number, gender and race.) MAKE SURE TO ENTER THE ACTUAL TEST DATE.

*Click on the ‘Go To’ box. Click on ‘Database Utilities’. Four tabs will display. They are: Export Study, Import Study, Move Study and Predicted.

*Click on ‘Move Study’. There are 2 large boxes on this screen. On the left side you need to enter the ID number of the study that you want to move by clicking on ‘Search’ at the bottom and entering the number in the box that pops up. (This would be the incorrect number. If you don’t have it, click on the same ‘Search’ button at the bottom of the left side and do a search.)

*When the correct name appears, double click on it and then select the correct test date. All of the tests dates for a participant, if there are more than one, appear under the name after you double click.

*Then go over to the right side of screen and search for the new (correct) number. Highlight the name when it appears. Don’t double click.

*When you see the correct name, go to the column in-between the left and right sides. There is an arrow in a box in this space. Click on it. A message box appears asking you if you really want to transfer the test from one number to the other number. You have a chance to double check your information here. If all info is now correct, click on ‘Yes’. You will see a message that this move was successful.

*If you then do a “Search” again on the studies you moved, you will notice that there will be one with the correct time and date and one with just the correct date. The one with only the correct date does not contain any test data. To delete this date from the cache (which is just for housekeeping purposes) click on “Tools”, then Cache Management, then tab “FHS-DT-PFS101”. Scroll to the correct participant’s number and you can delete the item with JUST THE DATE. Do not delete the item with the correct date AND TIME. This is the actual test data.